Bio

FDA Registration(s)#

Registered Device Listings#

Product Codes Associated With Registrations#

NDC#

• Fludeoxyglucose

  Biomedical Research Foundation of Northwest Louisiana

  Fludeoxyglucose F-18

• Sodium Fluoride F 18

  Biomedical Research Foundation of Northwest Louisiana

  SODIUM FLUORIDE F-18

• Fludeoxyglucose F18

  Biomedical Research Foundation of Northwest Louisiana

  Fludeoxyglucose F-18

• Ammonia N 13

  Biomedical Research Foundation of Northwest Louisiana

  Ammonia N-13

• PRO-TECT SUNSCREEN FOR PROFESSIONALS

  Bio-Medical & Pharmaceutical Manufacturing Corporation

  Meradimate, Octinoxate, Octisalate, Oxybenzone

• PRO-TECT SPORTS SUNSCREEN

  Bio-Medical & Pharmaceutical Manufacturing Corporation

  Meradimate, Octinoxate, Octisalate, Oxybenzone

• PRO-TECT SPORTS SUNSCREEN

  Bio-Medical & Pharmaceutical Manufacturing Corporation

  Meradimate, Octinoxate, Octisalate, Oxybenzone

• ANTIMICROBIAL FACE BODY WASH

  Bio-Medical & Pharmaceutical Manufacturing Corporation

  benzethonium chloride liquid

• Broad Spectrum SPF 30 Up The Anti

  Biopelle, Inc.

  TITANIUM DIOXIDE, ZINC OXIDE

• Ligatone

  BioActive Nutritional, Inc.

  Arnica Montana, Bryonia, Calcarea Phosphorica, Causticum, Kali Carbonicum, Manganese Gluconate, Mezereum, Rhus Tox, Ruta Graveolens, Silicea

• Pituitary Forte

  BioActive Nutritional, Inc.

  Hypophysis Suis, Hypothalamus (Suis), Pineal (Suis)

• Thyrotox

  BioActive Nutritional, Inc.

  Chondrus Crispus, Fucus Vesiculosus, Thyroidinum, Belladonna, Calcarea Carbonica, Conium Maculatum, Iodium, Kali Carbonicum, Phosphorus, Pulsatilla (Vulgaris), Silicea

• Allerforce

  BioActive Nutritional, Inc.

  Chondrus Crispus, Glycyrrhiza Glabra, Sarsaparilla, Zingiber Officinale, Adrenalinum, Allium Cepa, Aralia Racemosa, Arsenicum Album, Calcarea Carbonica, Cantharis, Iodium, Natrum Carbonicum, Rhus Tox,

• Melatonin Forte

  BioActive Nutritional, Inc.

  Melatonin, Nadidum, Niacin, Pyridoxinum Hydrochloricum, Zincum Sulphuricum, Hypophysis Suis, Hypothalamus (Suis), Lithium Carbonicum, Magnesia Carbonica, Pineal (Suis)

• NADH Plus

  BioActive Nutritional

  Nadidum, Adenosinum Cyclophosphoricum, Calcium D-Pantothenate, Cholinum, Riboflavinum, Ubidecarenonum, Dimethyl Glycine

• Endocrine Balancer

  BioActive Nutritional, Inc.

  Fucus Vesiculosus, Glycyrrhiza Glabra, Sarsaparilla, Glandula Suprarenalis Suis, Pinus Sylvestris, Thyroidinum (Suis), Iodium

• Hemoforce

  BioActive Nutritional, Inc.

  Urtica Urens, Ferrum Muriaticum, Aranea Diadema, Aurum Metallicum, Cinchona Officinalis, Cobaltum Gluconate, Phosphorus

• Hypopituitaryplex

  BioActive Nutritional, Inc.

  Aralia Quinquefolia, Hydrocotyle Asiatica, Polygonum Multiflorum, Hypophysis Suis, Hypothalamus Suis, Germanium Sesquioxide, Pineal Gland (Suis)

• Gynobalance

  BioActive Nutritional, Inc.

  Dehydroepiandrosterone, Estradiol, Pregnenolone, Progesterone, Testosterone

• Otoflam

  BioActive Nutritional, Inc.

  Belladonna, Conium Maculatum, Dulcamara, Hepar Sulphuris Calcareum, Kali Bichromicum, Mercurius Solubilis, Pulsatilla (Vulgaris), Silicea, Chamomilla

• Tri Estrogen

  BioActive Nutritional

  Folliculinum, Oophorinum,

• Thyroid HP

  BioActive Nutritional, Inc.

  Baryta Carbonica, Calcarea Carbonica, Fucus Vesiculosus, Iodium, Natrum Muriaticum, Pulsatilla, Spongia Tosta, Thyroidinum (Suis)

• ANX HP

  BioActive Nutritional, Inc.

  Arsenicum Album, Calcarea Carbonica, Ignatia Amara, Kali Carbonicum, Lachesis Mutus, Natrum Muriaticum

• LGB

  BioActive Nutritional, Inc.

  Belladonna, Chelidonium Majus, Colocynthis, Lycopodium Clavatum, Natrum Sulphuricum, Nux Vomica, Phosphorus, Pulsatilla (Vulgaris), Veratrum Album

• DHEA Forte

  BioActive Nutritionals, Inc.

  Dehydroepiandrosterone (DHEA), Pregnenolone, Progesterone,

• Adrenal Tonic

  BioActive Nutritional, Inc.

  Aralia Quinquefolia, Glycyrrhiza Glabra, Sarsaparilla, Avena Sativa, Glandula Suprarenalis Bovine, Adrenalinum, Arsenicum Album, Kali Phosphoricum, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Veratrum Album

• Allerpoll

  BioActive Nutritional, Inc.

  Allium Cepa, Ambrosia Artemisiaefolia, Arsenicum Album, Euphrasia Officinalis, Nux Vomica, Phosphorus, Pulsatilla (Vulgaris), Solidago Virgaurea, Sulphur

• Pre Post Surgery

  BioActive Nutritional, Inc.

  Hypericum Perforatum, Symphytum Officinale, Arnica Montana

• Hypothalamus

  BioActive Nutritional, Inc.

  Aralia Quinquefolia, Germanium Sesquioxide, Hydrocotyle Asiatica, Hypophysis Suis, Hypothalamus Suis, Pineal Gland (Suis), Polygonum Multiflorum, Carcinosin

• Cystoges

  BioActive Nutritional, Inc.

  Berberis Vulgaris, Cantharis, Clematis Erecta, Lac Caninum, Lycopodium Clavatum, Pulsatilla (Vulgaris), Sarsaparilla, Sepia, Staphysagria

• Quercetin

  BioActive Nutritional, Inc.

  Quercetin

• Arnica

  BioActive Nutritional, Inc.

  Arnica Montana

• Cardio Tonic

  BioActive Nutritional, Inc.

  Kali Muriaticum, Kali Phosphoricum, Plantago Major, Cactus Grandiflorus, Digitalis Purpurea, Heart (Bovine), L-Carnitine, L-Valine, Thyroidinum (Suis), Abrotanum (Artemisia Abrotanum), Iodium, Lecithin, Spigelia Anthelmia

• Estrogen

  BioActive Nutritional, Inc.

  Folliculinum, Oophorinum

• Cough HP

  BioActive Nutritional, Inc.

  Arsenicum Album, Bryonia (Alba), Cuprum Aceticum, Drosera (Rotundifolia), Ipecacuanha, Kali Carbonicum, Phosphorus, Pulsatilla (Vulgaris), Spongia Tosta

• Hydrate

  BioActive Nutritional, Inc.

  Coffea Tosta, Avena Sativa, Equisetum Hyemale, Hypericum Performatum, Ginkgo Biloba, Germanium Sesquioxide, Silicea

• Natural Progesterone

  BioActive Nutritional, Inc.

  Progesterone

• Melatonin

  BioActive Nutritional, Inc.

  Melatonin

• Bio Iodine

  BioActive Nutritional, Inc.

  Iodium

• Dentaforce

  BioActive Nutritional, Inc.

  Antimonium Crudum, Belladonna, Calcarea Carbonica, Calcarea Fluorica, Calcarea Phosphorica, Hekla Lava, Mercurius Solubilis, Plumbum Metallicum, Sepia, Silicea, Hydrofluoricum Acidum

200 records. Showing 1-40. Next

PMA#

• Protego EP PASSION

  2023-01-16

  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 ...

• Protego EP PASSION

  2023-01-16

  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 ...

• Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U

  2023-01-12

  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/c...

• Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U

  2023-01-12

  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/c...

• Pacemaker/ICD/CRT Non-Implanted Components PSW 2202.U and NEO 2202.U

  2023-01-12

  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/c...

• Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes

  2022-12-16

  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 - Ma...

• Drug-Eluting Permanent Defibrillator Electrodes

  2022-12-16

  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 - Ma...

• Defibrillator, implantable, dual-chamber

  2022-12-07

  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 - Ma...

• Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P)

  2022-12-07

  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 - Ma...

• Implantable Cardioverter Defibrillator (Non-CRT), Defibrillator, implantable, dual-chamber, Defibrillator, automatic imp

  2022-12-07

  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 - Ma...

• Implantable Cardioverter Defibrillator (Non-CRT)

  2022-12-07

  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 - Ma...

• Pulse Generator, Permanent, Implantable

  2022-12-07

  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 - Ma...

• DataBridge 4G/LTE Adapter

  2022-12-02

  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/c...

• QDOT MICRO™ System

  2022-11-23

  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

• Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode

  2022-11-16

  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 - Ma...

• Oxford® Partial Knee System

  2022-10-25

  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 Rea...

• Permanent Defibrillator Electrodes

  2022-10-20

  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 - Ma...

• Drug Eluting Permanent Left Ventricular (LV) Pacemaker Electrode

  2022-10-20

  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 - Ma...

• Drug Eluting Permanent Right Ventricular (RV), Right Atrial (RA) Pacemaker Electrodes

  2022-10-20

  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 - Ma...

• DUROLANE

  2022-10-14

  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 -...

• NaviStar RMT Catheter, NaviStar Catheter, EZ Steer NAV Catheter,

  2022-09-30

  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 Pro...

• Celsius Catheter, Celsius RMT Catheter, Celsius FLTR, Deflectable Diagnostic/Ablation Catheter, EZ Steer Catheter, EZ St

  2022-09-30

  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 Proc...

• ThermoCool SmartTouch Catheters, NaviStar ThermoCool Catheter, NaviStar RMT ThermoCool Catheter, EZ Steer ThermoCool NAV

  2022-09-30

  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 Pro...

• Celsius RMT ThermoCool Cather, Celsius ThermoCool Cather, EZ Steer ThermoCool Catheter, EZ Steer ThermoCool NAV Catheter

  2022-09-30

  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 Pro...

• Celsius FLTRR, EZ Steer Nav DS Catheter

  2022-09-30

  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 Pro...

• Biosense Webster Cables

  2022-09-30

  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 Pro...

• Pulse Generator, Permanent, Implantable

  2022-09-15

  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 - Ma...

• Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (CRT-P)

  2022-09-15

  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 - Ma...

• 8mm Dual Sensor (DS) Catheters

  2022-09-09

  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 Rea...

• CELSIUS

  2022-09-09

  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 Reas...

• CELSIUS THERMOCOOL, NAVISTAR THERMOCOOL, THERMOCOOL EZ STEER, THERMOCOOL SF, THERMOCOOL SMARTTOUCH (ST), THERMOCOOL SMAR

  2022-09-09

  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 Rea...

• NAVISTAR THERMOCOOL, THERMOCOOL SMARTTOUCH (ST)

  2022-09-09

  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 Rea...

• NAVISTAR

  2022-09-09

  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 Rea...

• Edora 8 HF-T QP, Edora 8 HF-T, Evity 8 HF-T QP, Evity 8 HF-T, Enitra 8 HF-T QP, Enitra 8 HF-T, Enticos 8 HF-T QP, Entico

  2022-08-22

  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 - Ma...

• Edora 8 DR-T, Evity 8 DR-T, Enitra 8 DR-T, Enticos 8 DR-T, Evity 6 DR-T, Enitra 6 DR-T, Edora 8 DR, Enitra 6 DR, Enticos

  2022-08-22

  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 - Ma...

• Orsiro Mission Sirolimus Eluting Coronary Stent System, Orsiro Sirolimus Eluting Coronary Stent System

  2022-08-05

  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 - Man...

• Astron Peripheral Self-Expanding Nitinol Stent System

  2022-07-27

  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 - Ma...

• PRO-Kinetic Energy Coronary Stent System

  2022-07-27

  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 - Ma...

• Astron Pulsar Stent System, Pulsar-18 Stent System

  2022-07-27

  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 - Ma...

• Orsiro Sirolimus Eluting Coronary Stent System, Orsiro Mission Sirolimus Eluting Coronary Stent System

  2022-07-27

  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 - Man...

200 records. Showing 1-40. Next

PMN#

• Remote Wave Electrode (AE03-50); Remote Wave Electrode (AE03-60)

  2026-03-12

  Bionit Labs Srl

• Bio Arterial Deluxe (IC-BAP-DX)

  2025-12-12

  Bio Compression Systems, Inc.

• PnueAira (PNCU-01)

  2025-08-18

  Biotab, LLC

• StimTrial Neuromodulation System

  2025-07-16

  Bioventus, LLC

• TalisMann Neuromodulation System

  2025-07-03

  Bioventus, LLC

• Synicem Hip Spacer; Synicem Knee Spacer; Synicem Shoulder Spacer

  2025-06-12

  Biocomposites, Ltd.

• ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)

  2025-06-12

  Biomérieux

• ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)

  2025-04-30

  Biomerieux S.A.

• VITEK COMPACT PRO

  2025-03-14

  bioMerieux, Inc.

• IceCap product line

  2025-03-13

  Bioserenity Medical Devices Group

• BioFire Warrior Panel; BioFire Warrior Panel Control Kit

  2025-03-12

  Biofire Defense, LLC

• XT3 System

  2025-01-22

  Biodynamik, Inc.

• BIOFIRE FILMARRAY Gastrointestinal (GI) Panel Mid

  2025-01-16

  Biofire Diagnostics, LLC

• BB-613-BPM

  2025-01-14

  Biobeat Technologies , Ltd.

• Wave Electrode (AE02-60); Wave Electrode (AE02-50)

  2025-01-02

  Bionit Labs Srl

• Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)

  2024-12-30

  Bios S.R.L.

• BIOFIRE Blood Culture Identification 2 (BCID2) Panel (RFIT-ASY-0147 (30 pack) RFIT-ASY-0148 (6 pack))

  2024-12-20

  Biofire Diagnostics, LLC

• Bioscope Neuromonitor Device

  2024-12-13

  Biosys Biyomedikal Muhendislik San. VE Tic. A.S.

• BIOFIRE FILMARRAY Tropical Fever Panel

  2024-12-05

  Biofire Diagnostics, LLC (Biomerieux)

• BIOFIRE FILMARRAY Gastrointestinal (GI) Panel

  2024-11-07

  Biofire Diagnostics, LLC

• Accelx Implant System

  2024-11-06

  Biotech Dental, LLC

• BIOFIRE® FILMARRAY® Pneumonia Panel (BIOFIRE Pneumonia Panel); BIOFIRE® FILMARRAY® Pneumonia Panel plus (BIOFIRE Pneumonia Panel plus)

  2024-11-06

  Biofire Diagnostics, LLC (Biomerieux)

• RIGHTEST Blood Glucose Monitoring System Max Tel

  2024-11-04

  Bionime Corporation

• Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo

  2024-10-31

  Bionova Medical, Inc.

• Pantera Pro; Pantera LEO

  2024-10-25

  Biotronik, Inc.

• Immediate Molar Implants

  2024-10-23

  Biomet 3i, LLC

• BioButton System

  2024-09-26

  Biointellisense, Inc.

• Pectus Blu Support Bar System

  2024-09-19

  Biomet Microfixation

• Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)

  2024-09-12

  Biotronik, Inc.

• Morph DNA Steerable Introducer Sheath

  2024-08-23

  Biocardia

• Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo

  2024-08-21

  Bionova Medical, Inc.

• ADVIA Centaur EBV-EBNA IgG

  2024-08-07

  Biokit, S.A.

• ADVIA Centaur EBV-VCA IgM

  2024-08-07

  Biokit, S.A.

• SmartShape? Healing Abutment; Wide Custom Milled Ti-Blank Abutment

  2024-07-30

  BioHorizons Implant Systems, Inc.

• BellaTek Bars

  2024-07-15

  Biomet 3i, LLC

• Oscar Peripheral Multifunctional Catheter system

  2024-07-11

  Biotronik, Inc.

• Hello,eyes® BIO Plug

  2024-06-28

  Bio Optics Co., Ltd.

• NUVISION? Ultrasound Catheter; NUVISION? NAV Ultrasound Catheter

  2024-06-28

  Biosense Webster, Inc.

• Allograft Delivery Device (OFAC-C)

  2024-06-25

  Bioventus, LLC

• Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)

  2024-06-14

  Bios S.R.L.

200 records. Showing 1-40. Next

Applications#

• 761436

  BIOCON BIOLOGICS INC

• 761419

  BIO-THERA SOLUTIONS LTD

• 761406

  BIOCON BIOLOGICS INC

• 761354

  BIOGEN MA

• 761274

  BIOCON BIOLOGICS INC

• 761198

  BIO-THERA SOLUTIONS LTD

• 761188

  BIOCON BIOLOGICS INC

• 761178

  BIOGEN INC

• 761175

  BIOCON BIOLOGICS INC

• 761164

  BIOVERATIV THERAPEUTICS INC

• 761079

  BIOMARIN PHARM

• 761052

  BIOMARIN PHARM

• 761029

  BIOGEN

• 220121

  BIOCON PHARMA LIMITED

• 220119

  BIOCON PHARMA LIMITED

• 220100

  BIONPHARMA

• 220062

  BIONPHARMA

• 219904

  BIONPHARMA

• 219776

  BIOCRYST

• 219443

  BIOCON PHARMA

• 219442

  BIOCON PHARMA

• 219289

  BIONPHARMA

• 219153

  BIONPHARMA

• 219152

  BIONPHARMA

• 219151

  BIONPHARMA

• 219123

  BIONPHARMA

• 218442

  BIOCON PHARMA LTD

• 218441

  BIOCON PHARMA LTD

• 218346

  BIOCON PHARMA

• 218290

  BIONPHARMA

• 218278

  BIOCON PHARMA

• 218221

  BIONPHARMA

• 218220

  BIONPHARMA

• 218149

  BIONPHARMA

• 218107

  BIOCON PHARMA

• 218070

  BIOCON PHARMA

• 218017

  BIONPHARMA

• 217917

  BIONPHARMA

• 217916

  BIONPHARMA

• 217555

  BIONPHARMA

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