Bio

FDA Filings

This page includes the latest FDA filings for Bio. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
NDC 71416-001 Bio	Protocoxil	2017-05-09

Similar & Related FDA Registered Companies

• BIOTIX, INC.
• Bioprober Corporation
• BIOTEQUE AMERICA, INC.
• BIOCOMPOSITES, INC.
• BioMed Resource Inc.
• Bio-Med USA Inc
• BIOMEDICORE INC.
• Biodex Inc.
• BIOMERICA, INC.
• Bion Enterprises, Ltd.
• BIO-RAD LABORATORIES, INC.
• bioMerieux, Inc.
• Bio-Rad Laboratories
• BIOMET 3I
• BIOTRONIK, INC.
• Biocartis US Inc
• Bio-Med USA
• BIONESS INC.
• Bio-Med
• Biosys Laboratories, Inc.
• Biologics Consulting Group. INC
• BIOMEDICAL SALES INTERNATIONAL, INC.
• BIOVIEW USA INC.
• BioHorizons Implant Systems Inc.
• BIOMETRICS INC.
• BIOSENSE WEBSTER, INC.
• Bio Business
• BIONET AMERICA, INC.
• Bio SB, Inc.
• Biolog-id
• Biopro
• Bio Protective Solutions, L.L.C.
• Bioforce USA
• Biologics Consulting Group
• Biofourmis Inc.
• bioMerieux
• BIOGENEX LABORATORIES, INC.
• BIONEER, INC.
• BioStor Systems, LLC
• BioSculptor Corporation
• BIO CONNECT SYSTEMS
• Bio Jouvance Inc
• Bio Pacific Inc
• Bio Parts Lab
• BIO PROTECH USA, INC.
• Bio Protective Solutions
• Bio Tech lubricants Ltd
• Bio Trading Inc
• BIO-CORE INC
• Bio-Gate
• Bio-Medical Instruments, Inc.
• BioAnue Health Products LLC
• BioCARE
• Biocartis NV
• Bioeasy USA, Inc.
• Biofeedback Instrument Co.
• Biofeedback Resources International
• Biogen Idec
• Biogenic Dental Corp
• Biohacked, Inc.
• BioJump LLC
• Biolabs
• BioLife Plasma Services
• Biologistex, Inc.
• BioMarin Pharmaceutical Inc.
• Biomarin Pharmaceuticals
• BioMaterials America, Inc.
• BIOMEDEQUIP, INC.
• Biomedical Internacional
• BIOMEDICAL LIFE SYSTEMS , INC.
• Biomedical Unlimited Inc.
• Bioneer Corporation
• BioNet Inc.
• Biopacific Diagnostic Corp
• biopsy forceps
• Bioptik Technology, Inc.
• BioRad Laboratories
• Bioreference Laboratories
• Bioresource Technology Inc.
• BioRx Laboratories
• Biosearch Medical
• Biosevica Inc
• BIOSTAT, LLC
• BioTech Screening, LLC
• Biotest Pharmaceuticals Corp
• BioVendor
• Bioverativ
• BioView Inc.
• BIOWAVES, LLC.
• BIOWORLD MERCHANDISING, INC.
• Bio Components, LLC
• BIO COMPOSANTS MEDICAUX (BCM)
• Bio Compression Systems, Inc
• BIO CONCEPT Co., Ltd
• BIO COSMETICS S.L.
• Bio Energo W Lohmann GmbH
• Bio Gen Technologies Inc
• BIO MED SCIENCES, INC.
• Bio Medical Equipment Service Company (BMES)
• BIO NUCLEAR DIAGNOSTICS, INC.
• BIO PLAS, INC.
• Bio Protech USA
• BIO PROTECH, INC.
• BIO-ANALYSIS, INC.
• BIO-ART EQUIPAMENTOS ODONTOLOGICOS LTDA.
• BIO-CONCEPTS, INC.
• Bio-Form Technology Co., Ltd.
• BIO-HOSPITAL AB
• Bio-Logic Aqua Research Technologies Int.. Inc
• BIO-MAX TECH CO., LTD
• BIO-MED DEVICES, INC.
• BIO-MEDICAL DEVICES
• BIO-MEDICAL RESEARCH LTD
• Bio-Nuclear of PR, Inc
• Bio-One, Inc.
• BIO-OPTICA MILANO SPA
• BIO-RAD
• Bio-Rad Medical Diagnostics GmbH
• BIO-RESEARCH ASSOCIATES, INC.
• BIO-TEST MEDICAL, INC.
• BIO/DATA CORP.
• Bio2 Technologies, Inc.
• BIOACCESS, INC.
• Bioanalytic GmbH
• Bioarray Solutions Limited
• Biobase Biodustry(Shandong)Co., Ltd
• Biobase Scientific (Shandong) Co.,Ltd
• Biobot Surgical Pte. Ltd.
• BioBrdige Global
• Biocan Diagnostics Inc
• BIOCARDIA, INC.
• Biocare Corporation
• BIOCARE HOLDINGS, LLC
• BIOCELLKOREA CO., LTD.
• BioCer Entwicklungs-GmbH
• BIOCHECK, INC.
• BIOCHEMICAL DIAGNOSTICS, INC.
• BIOCLEAR
• BioClin BV
• BioClinica, Inc.
• BioCollections Worldwide, Inc.
• BIOCOMPOSITES LTD.
• BioCure, Inc.
• BIOCYTECH CORPORATION SDN BHD
• Bioda Diagnostics(Wuhan)Co.,Ltd
• Biodapt, Inc.
• Biodaptive Advanced Materials LLC
• Biodaptive, LLC
• BIODENT /Khachi
• Biodenta Corporation
• Biodenta Swiss AG
• BIODERM, INC.
• BIODERMIS CORP.
• BioDetect (Xiamen)Biotechnology Co.,Ltd.
• BIODEX MEDICAL SYSTEMS, INC.
• Biodominium Diagnostics
• BIODYNAMICS CORP.
• BioElectronics Corporation
• BIOENGINEERING LABORATORIES Srl
• Biofarmitalia S.R.L
• Biofast Biotech Originality Study Co. Ltd.
• BIOFILM, INC.
• BioFlo, LLC
• Biofortuna Ltd.
• BIOFOURMIS SINGAPORE PTE LTD
• Biofrontera Pharma GmbH
• Biofunctional Materials
• Biofusion Medical
• BioGend Therapeutics Co., Ltd.
• Biogenetics Corporation
• BioGeniv, Inc.
• Biogennix, LLC
• Biohit Healthcare (Hefei) Co., Ltd.
• Biohit OYJ
• BioIntelliSense Inc.
• BioIQ
• Biokinemetrics, Inc.
• BIOKIT S.A.
• BIOKOSMES SRL
• BIOLAND TECHNOLOGY LTD.
• BIOLASE, INC.
• Biolegend, Inc
• Biolidics Limited
• BIOLIFE DIGNITY HEALTH INTERNATIONAL LIMITED
• BioLife Plasma Services L.P. (Baxalta US Inc.)
• BIOLIFE, LLC
• BioLink Systems, LLC
• BIOLOG, INC.
• Biological Industries Israel Beit Haemek LTD
• Biological Industries USA, Inc
• BIOLOGICS, INC.
• BIOLOREN SRL
• Biolux Research Holdings Inc.
• Biolytical Laboratories Inc.
• Biom'up France SAS
• BioMagnetic Sciences, LLC
• BioMarin Pharmaceutical
• BIOMAT SCIENCES, INC.
• Biomat USA, Inc.
• BIOMATE MEDICAL DEVICES TECHNOLOGY CO., LTD
• BIOMATERIALS KOREA INC.
• BIOMATLANTE
• Biomdtek Company Limited
• Biomed Diagnostics, Inc
• BIOMED LABORATORIES LLC
• BIOMED Labordiagnostik GmbH
• BioMed Ventures
• BioMedica Diagnostics Inc.
• Biomedical Devices of Kansas
• BioMedical Enterprises, Inc.
• BIOMEDICAL POLYMERS, INC. dba BMP Medical
• Biomedical Regenerative GF, LLC.
• BIOMEDIZINISCHE INSTRUMENTE & PRODUKTE,GMBH(BIP)
• BioMedomics, Inc.
• Biomedovation
• Biomeme, Inc.
• Biomerics
• Biomerics ATL, LLC
• Biomerics FMI
• BIOMERIEUX SA
• BIOMET MICROFIXATION
• Biomet, Inc.
• biometerplususa
• BIOMETRICS LTD
• BIOMIST, INC.
• Biomobie (Shanghai) Regenerative Medicine Co., Ltd.
• BioMTA
• Bioncise NV
• Bionen s.a.s
• BIONEOVAN Co., LTD.
• BIONET COMPANY LTD
• Bionic Gym
• Bionik, Inc.
• Bioniks
• BIONIME CORPORATION
• BIONIME USA CORPORATION
• BIONIX DEVELOPMENT CORP.
• BIONOSTICS, INC.
• Bionova Medical, Inc.
• Biontech Co.,Ltd
• Bionwater international LLC.
• BIOPAC Systems, Inc.
• BIOPHARM UK LTD
• Biophotas, Inc.
• Bioplate, Inc.
• BIOPLEXUS LLC
• BioPoly, LLC
• BIOPRO (M) SDN BHD
• BIOPRO, INC.
• Bioprod d.o.o.
• Biopsy Fine Cut Instruments
• BIOPSYBELL S.R.L.
• BIOPTRON AG
• Bior Medica srl
• BIORAD MEDISYS PVT. LTD.
• BioRegen Biomedical (Changzhou) Co., Ltd
• Biorep Technologies, Inc.
• Bioretec Ltd.
• Biorex Labs LLC
• BIOS S.R.L.
• BioSAF IN Srl
• BIOSAFE SA
• BioSafe Supplies, LLC
• BIOSCREEN INC.
• BIOSEAL
• BIOSEARCH MEDICAL PRODUCTS, INC.
• Biosearch Technologies Inc.
• BioSensics
• BIOSERENITY
• Bioserv Corporation
• BIOSERV DIAGNOSTICS
• BioSig Technologies
• BIOSIGMA SRL
• Biosonic Technologies, LLC
• Biosonix
• BioStable Science & Engineering
• BIOSTECH CO., LTD.
• BIOSYNERGY, INC.
• BioTE Medical, LLC
• Biotec BetaGlucans AS
• BIOTEC, INC.
• Biotech Innova
• Biotech Medical Technology Co.,Ltd.
• Biotech, Inc.
• Biotegy Corporation
• BIOTEK INSTRUMENTS, INC.
• Biotem Co., Ltd.
• BIOTEQUE CORP
• BIOTEX, INC.
• BioTrace Medical, Inc.
• Biotricity
• BIOTRONIK AG
• BIOTRONIK SE & CO. KG
• Biotronix Healthcare Industries Inc.
• Biovation Orthopaedic Solutions LTD
• Bioventus LLC
• BIOVIEW LTD.
• BIOVISION
• Biovision Holdings
• Biovo Technologies
• BioWare Technologies Co., Ltd.
• BIOWAVE CORPORATION
• Bioway Biological Technology Co., Ltd
• Biowy Corporation
• BioXtreme
• BioFire Diagnostics, LLC
• BioFire Defense, LLC
• Biomet 3i LLC
• Biovica International AB
• Biotech Dental, SAS
• BioCircuit Technologies, Incorporated
• BioMérieux SA
• BioTeke Corporation (WuXi) Co., Ltd
• BioBeat Technologies Ltd.
• BioMérieux, Inc
• Biomet Micofixation
• Biomet Manufacturing Corp.
• Biotronick, Inc.
• Biotech Dental Smilers, SAS
• Biorez, Inc.
• Biostone Ltd
• Bioden Co., Ltd
• BioWink GmbH
• BioCore9 LLC
• Bioserenity SAS
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS170 Date Received11/30/2022 Decision Date01/16/2023 Product Code MRM  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS118 Date Received11/30/2022 Decision Date01/16/2023 Product Code LWS  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP000009 Supplement NumberS100 Date Received11/15/2022 Decision Date01/12/2023 Product Code MRM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS169 Date Received11/15/2022 Decision Date01/12/2023 Product Code MRM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS143 Date Received11/15/2022 Decision Date01/12/2023 Product Code NKE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS243 Date Received11/23/2022 Decision Date12/16/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS117 Date Received11/23/2022 Decision Date12/16/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP000009 Supplement NumberS099 Date Received11/10/2022 Decision Date12/07/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS168 Date Received11/10/2022 Decision Date12/07/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS142 Date Received11/10/2022 Decision Date12/07/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS241 Date Received11/10/2022 Decision Date12/07/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS116 Date Received11/10/2022 Decision Date12/07/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS240 Date Received09/26/2022 Decision Date12/02/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Biosense Webster, Inc.31 Technology Drive, Suite 200irvine, CA 92618 PMA NumberP210027 Date Received07/06/2021 Decision Date11/23/2022 Product Codes OAD OAE  Advisory Committee Cardiovascular Clinical TrialsNCT03775512 Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS141 Date Received10/18/2022 Decision Date11/16/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOMET MANUFACTURING CORP.56 East Bell Drivep.o. Box 587warsaw, IN 46581-0587 PMA NumberP010014 Supplement NumberS103 Date Received09/29/2022 Decision Date10/25/2022 Product Code NRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS140 Date Received09/22/2022 Decision Date10/20/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS239 Date Received09/22/2022 Decision Date10/20/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS115 Date Received09/22/2022 Decision Date10/20/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Bioventus LLC4721 Emperor Blvd, Suite 100durham, NC 27703 PMA NumberP170007 Supplement NumberS014 Date Received09/14/2022 Decision Date10/14/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP010068 Supplement NumberS070 Date Received09/02/2022 Decision Date09/30/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP030031 Supplement NumberS128 Date Received09/02/2022 Decision Date09/30/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP040036 Supplement NumberS090 Date Received09/02/2022 Decision Date09/30/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990025 Supplement NumberS070 Date Received09/02/2022 Decision Date09/30/2022 Product Code DRF  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS056 Date Received09/02/2022 Decision Date09/30/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Biosense Webster, Inc31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP950005 Supplement NumberS085 Date Received09/02/2022 Decision Date09/30/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS139 Date Received08/29/2022 Decision Date09/15/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS238 Date Received08/29/2022 Decision Date09/15/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP010068 Supplement NumberS069 Date Received06/10/2022 Decision Date09/09/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP030031 Supplement NumberS127 Date Received06/10/2022 Decision Date09/09/2022 Product Code OAD  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP040036 Supplement NumberS089 Date Received06/10/2022 Decision Date09/09/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990025 Supplement NumberS069 Date Received06/10/2022 Decision Date09/09/2022 Product Code DRF  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• Biosense Webster, Inc31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP950005 Supplement NumberS084 Date Received06/10/2022 Decision Date09/09/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS138 Date Received08/03/2022 Decision Date08/22/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS237 Date Received08/03/2022 Decision Date08/22/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Biotronik, Inc6024 Jean Roadlake Oswego, OR 97035 PMA NumberP170030 Supplement NumberS026 Date Received07/07/2022 Decision Date08/05/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP140030 Supplement NumberS015 Date Received06/21/2022 Decision Date07/27/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP160003 Supplement NumberS015 Date Received06/21/2022 Decision Date07/27/2022 Product Code MAF  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP160025 Supplement NumberS015 Date Received06/21/2022 Decision Date07/27/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Biotronik, Inc6024 Jean Roadlake Oswego, OR 97035 PMA NumberP170030 Supplement NumberS024 Date Received06/21/2022 Decision Date07/27/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOMET MANUFACTURING CORP.56 East Bell Drivep.o. Box 587warsaw, IN 46581-0587 PMA NumberP010014 Supplement NumberS102 Date Received06/14/2022 Decision Date07/14/2022 Product Code NRA  Advisory Committee Orthopedic Supplement Typespecial (immediate Track) Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP000009 Supplement NumberS098 Date Received06/17/2022 Decision Date06/21/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS167 Date Received06/17/2022 Decision Date06/21/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS137 Date Received06/17/2022 Decision Date06/21/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS236 Date Received06/17/2022 Decision Date06/21/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS114 Date Received06/17/2022 Decision Date06/21/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOMIMETIC THERAPEUTICS,LLC389 Nichol Mill Lnfranklin, TN 37067 PMA NumberP100006 Supplement NumberS013 Date Received12/15/2021 Decision Date06/13/2022 Product Code NOX  Advisory Committee Orthopedic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS054 Date Received05/18/2022 Decision Date06/08/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP160025 Supplement NumberS014 Date Received04/20/2022 Decision Date05/20/2022 Product Code NIP  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Biom'Up France SAS8 Allee Irene Joliot Curiesaint-priest 69800 PMA NumberP170012 Supplement NumberS028 Date Received11/23/2021 Decision Date04/22/2022 Product Code PMX  Advisory Committee General & Plastic Surgery Supplement Type135 Review Track For 30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Biosensors International USA, Inc.1013 Centre Rd.suite 228wilmington, DE 19805 PMA NumberP190020 Date Received08/16/2019 Decision Date04/14/2022 Product Code NIQ  Advisory Committee Cardiovascular Clinical TrialsNCT02843633 Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP000009 Supplement NumberS097 Date Received02/07/2022 Decision Date04/11/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS166 Date Received02/07/2022 Decision Date04/11/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS136 Date Received02/07/2022 Decision Date04/11/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOMET MANUFACTURING CORP.56 East Bell Drivep.o. Box 587warsaw, IN 46581-0587 PMA NumberP010014 Supplement NumberS101 Date Received03/11/2022 Decision Date04/04/2022 Product Code NRA  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOSENSE WEBSTER, INC.31 Technology Drivesuite 200irvine, CA 92618 PMA NumberP990071 Supplement NumberS053 Date Received02/16/2022 Decision Date03/15/2022 Product Code LPB  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS235 Date Received02/17/2022 Decision Date03/15/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP980023 Supplement NumberS112 Date Received02/17/2022 Decision Date03/15/2022 Product Code LWS  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP050023 Supplement NumberS165 Date Received12/08/2021 Decision Date03/08/2022 Product Code MRM  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP950037 Supplement NumberS233 Date Received01/05/2022 Decision Date03/04/2022 Product Code DXY  Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track No User Fee Supplement Reason Labeling Change - Pas Expedited Review Granted? No
• Bioventus LLC4721 Emperor Blvd, Suite 100durham, NC 27703 PMA NumberP170007 Supplement NumberS013 Date Received02/03/2022 Decision Date03/03/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Bioventus LLC4721 Emperor Blvd, Suite 100durham, NC 27703 PMA NumberP170007 Supplement NumberS012 Date Received02/03/2022 Decision Date03/02/2022 Product Code MOZ  Advisory Committee Orthopedic Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOTRONIK, INC.6024 Jean Roadlake Oswego, OR 97035 PMA NumberP070008 Supplement NumberS135 Date Received02/01/2022 Decision Date02/28/2022 Product Code NKE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• Biotronik, Inc6024 Jean Roadlake Oswego, OR 97035 PMA NumberP170030 Supplement NumberS021 Date Received01/31/2022 Decision Date02/23/2022 Product Code NIQ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• BIOMIMETIC THERAPEUTICS,LLC
• Biosphere Medical S.A.
• BIOSITE INCORPORATED
• Bio 2
• Bio Chemics
• Bio Cosmetics
• Bio Direct Ltd.
• BIO EARTH MANUFACTURING (PTY) LTD
• BIO HEALING THERAPY INDUSTRIES INC
• Bio Jouvance
• BIO ME INC
• BIO NUCLEONICS INC
• Bio Products Laboratory Limited
• Bio Shine, Inc.
• BIO SPECTRA
• Bio System de Mexico SA de CV
• Bio Systems de Mexico SA de CV
• Bio Tech Research Labs
• BIO CENTRIC INC.
• BIO COSMETICS SL
• Bio Medical Innovations
• Bio-Dent, Inc.
• BIO-DETEK INCORPORATED
• BIO-LIFE INNOVATIONS, LLC
• BIO-MED DIAGNOSTICS, INC.
• Bio-Reference Laboratories, Inc.
• BIO-VIEW LTD
• BIO2 MEDICAL INC
• BIOANALYTIC GmbH, biomed. Analysentechnik
• BIOCARE MEDICAL LLC
• BIOCARE SYSTEMS INC
• BIOCHROM LIMITED
• Bioclear Matrix Systems
• BIOCOMPATIBLES UK LTD
• Biocomposites GmbH
• Biodesix, Inc.
• BioEcho Life Sciences GmbH
• BIOFUNCTIONAL MATERIALS LLC
• BioGenetics CO.,LTD.
• BIOGENEX LABORATORIES
• Biolab Equipment Ltd
• Biolux Research Limited
• Biolux Technology GmbH
• BIOM' UP
• Biomedica ADI Inc.
• BIOMEDICAL DATA SOLUTIONS LIMITED
• Biomedical Polymers, Inc.
• BIOMEDIX-INC
• BIOMERICS, LLC
• BIOMET
• Biomet Biologics, LLC
• BIOMET MICROFIXATION, INC
• Biomet Orthopedics, LLC
• BIOMET SPAIN ORTHOPAEDICS SL
• BIOMET SPINE LLC
• Biomet Sports Medicine, LLC
• Biomet Uk Ltd
• Bioncise
• BIONICM INC.
• BIONIT LABS SRL
• BIONIX RADIATION THERAPY, LLC
• Bionix, LLC
• BIONNOVATION PRODUTOS BIOMEDICOS LTDA.
• BIONX MEDICAL TECHNOLOGIES, INC.
• BIOPROTECH INC.
• BIOPROTECT LTD
• BIOPTIGEN, INC.
• BIOPTIMAL INTERNATIONAL PTE. LTD.
• Bioresource Technology
• Bioretec Oy
• BIOSENSE WEBSTER (ISRAEL) LTD.
• BIOSENSICS LLC
• BIOSERENITY MEDICAL DEVICES GROUP
• BIOSIG TECHNOLOGIES, INC.
• BIOSPHERE MEDICAL
• BIOSTABLE ENGINEERING & SCIENCE
• BIOSTONE CO. LIMITED
• BIOSTRUCTURES, LLC
• BIOTECH DENTAL
• BIOTECH DENTAL SMILERS
• BIOTECHNOLOGY INSTITUTE SL
• BIOTECNICA INSTRUMENTS SPA
• Bioteque Taiwan Ltd.
• BIOTEST MEDICAL CORPORATION
• BIOTRICITY INC
• Biover AG
• Biovision GmbH Entwicklung, Herstellung und Vertrieb von Biomaterialien
• BIOVISION TECHNOLOGIES, LLC
• BIOVO TECHNOLOGIES LTD
• BIOTEC ITALIA SRL
• Bio Optics Co., Ltd
• Bioporto Diagnostics A/S
• BIOTECNO INDUSTRIA E COMERCIO LTDA
• Bio-Medical Science & Technology LIMITED