FDA.reportPublic FDA data

Bio

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
BIO-GRAM DIAGNOSTICS GMBH5N2026-01-01Altrheinstrasse 12 Worms Rhineland-Palatinate DE 67550
BIOMENDEX OY5N2026-01-01Korkeakoulunkatu 1 Tampere Pirkanmaa FI 33720
BIOTRICS BIOIMPLANTS AG5N2026-01-01Ullsteinstr. 108 Berlin DE 12109
BIOWICK HEALTHCARE PRIVATE LIMITED5N2026-01-01Plot no. 42 , Sector - A , Bagroda Industrial Area Bhopal Madhya Pradesh IN 462026
Bio-Med Healthcare Products Pvt. Ltd.5N2026-01-0149/4 Main Mathura Road Prithla Palwal Haryana IN 121102
10282321028232BIOTRONIK, INC.1Y2026-01-016024 JEAN RD. LAKE OSWEGO OR US 97035
10323471032347BIOMET MICROFIXATION1N2026-01-011520 Tradeport Dr Jacksonville FL US 32218
10558761000111217BioGeniv, INC1N2026-01-01640 Nu Way Circle NE Lenoir NC US 28645
10571961000140478Biomerics Mebane1N2026-01-011405 Dogwood Way Mebane NC US 27302
10589311000525241BIORESOURCE TECHNOLOGY1N2026-01-011800 N Commerce Pkwy Weston FL US 33326
10608181000592496BIOHORIZONS IMPLANT SYSTEMS INC.1Y2026-01-012300 RIVERCHASE CENTER BIRMINGHAM AL US 35244
10659823003029518BIOCOMPOSITES, INC.1Y2026-01-01700 Military Cutoff Rd Ste 320 Wilmington NC US 28405
10664213003395204BIOLIFE, LLC1N2026-01-018163 25th Ct E SARASOTA FL US 34243
10671433003750694BIOCURE SOLUTIONS, LLC DBA BIOCURE, INC.1N2026-01-012975 Gateway Dr Peachtree Corners GA US 30071
11246211000513050BIOACCESS, INC.1N2026-01-014000 HUDSON ST. BALTIMORE MD US 21224
11257303002838732BIOMAT SCIENCES, INC.1N2026-01-015612 Glenwood Rd BETHESDA MD US 20817
11262711000263641BioClinica, Inc.1N2026-01-011818 Market Street Philadelphia PA US 19103
12187043003952420BIO-MED DEVICES, INC.1N2026-01-0161 SOUNDVIEW RD GUILFORD CT US 06437
12205021220502Biomedical Polymers, Inc.1N2026-01-0116 Chocksett Road Sterling MA US 01564
12206491220649BIONOSTICS, INC.1N2026-01-017 JACKSON RD. Devens MA US 01434
14199681419968BION ENTERPRISES, LTD.1Y2026-01-01455 State St Ste 100 DES PLAINES IL US 60016
14504051450405BIOMERIEUX, INC.1N2026-01-011105 N Main St LOMBARD IL US 60148
15268541526854BIONIX, LLC1Y2026-01-011670 Indianwood Circle Maumee OH US 43537
16468311000160215BIOMERICS FMI1N2026-01-011605/1704/1700 Enterprise St. Athens TX US 75751
16503473002253377BIOMED MEDEQUIP INC.1Y2026-01-012804 Singleton Street Rowlett TX US 75088

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
281911713920620P980023PHYLAX IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMLWS1998-10-27
281911309454949P950037DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMSDXY1996-10-11
281911723237467P820076DIPLOS MODEL 05 A & BLWP1984-02-15
281911234382442P170030ORSIRO Sirolimus Eluting Coronary Stent SystemNIQ2019-02-22
281911183288798P070008STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEADNKE2008-05-12
281911754526466P050023TUPOS LV/ATX & KRONOS LV-T CRT-D & COROX OWT STEROID LV PACING LEADMRM2006-08-10
282671013060902P020016WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEMLZD2005-09-21
281911874963309P000009PHYLAX AV ICD SYSTEMMRM2000-09-29
518011308220832K993493THE AUTOTAC SYSTEMDZL2000-01-07
282671317338145K992961LORENZ SMALL FRAGMENT SYSTEMHRS1999-11-08
282671859980973K992952LORENZ DISTRACTION SYSTEMMQN1999-11-19
566771763583302K992838ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATEKLE1999-11-15
282671472800172K992355LACTOSORB TRAUMA PLATING SYSTEMHRS1999-12-20
282671684830220K992158LACTOSORB SHEETSJEY1999-08-20
282671879130763K990290CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLERGXP1999-11-18
518011844450069K990277O-RING ABUTMENTDZE1999-04-09
303542046724335K984261SURESTEP BLOOD GLUCOSE MONITORING SYSTEMCGA1999-05-21
282671156603292K983728LORENZ IMF SCREWDZL1999-05-13
303541595964019K983475HEMOCHRON RESPONSEKQG1999-05-03
303541741188639K982303PRECISION PCX POINT OF CARE MANAGEMENT SYSTEM , QC MANAGER DATA MANAGER SYSTEM, PRECISION G PLUS BLOOD GLUCOSE TEST STCGA1998-12-08
281911843737205K982272GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018DQX1999-01-08
282671449754667K981789LORENZ PECTUS SUPPORT BAR STABILIZERHRS1998-07-13
282671154749478K98107020-HOLE ADAPTATION PLATEJEY1998-05-20
282671581415731K980927LACTOSORB PANELS AND FASTENERSJEY1998-06-05
282672031446665K980512LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREWJEY1998-05-11
303541824569714K980178OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRYJJY1998-02-12
303541156237161K974822AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROLJJY1998-01-22
282671229699384K974309LACTOSORB PANELSHRS1998-01-30
282671877518770K974136CRANIOFACIAL ANCHORSMBI1998-01-30
769041919396307K973403CARDIOSMART STLOS1998-03-12
282671188307185K973080SURGICAL VASCULAR CLAMPDXC1998-02-23
303541080628556K972868TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROLJJY1997-08-28
282671679758144K972420LORENZ PECTUS SUPPORT BARHRS1997-08-11
282671369293463K972322LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATESJEY1997-08-18
518011109251455K972313THE MAESTRO SYSTEMDZE1997-09-16
282671876207441K972074SUCTION INSTRUMENTATIONGCX1997-07-25
281911413560754K971930BK-N SEALING CAPDTD1997-08-14
282671600712248K971870LACTOSORB TRAUMA PLATING SYSTEMHRS1997-08-19
303541975420511K970556SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEMCGA1997-05-12
281911436236894K970204BK-A; BK-B; BK-IS SEALING CAPDTD1997-04-29
518011963466389K964330BIOHORIZONS DENTAL IMPLANT SYSTEM (NAME SUBJECT TO CHANGE)DZE1997-01-17
281911853114577K964190ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZERDTE1997-07-10
303541799382188K961807CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4GLK1996-07-26
518011725540574K960026BIOHORIZONS DENTAL IMPLANT SYSTEMDZE1996-03-28
282671104533822K955729LACTOSORB TRAUMA PLATING SYSTEMHRS1996-02-14
303541367106057K955630RNA MEDICAL HEMAT CONTROLJJR1996-03-01
282671604185006K953385LORENZ 1.0MM, 1.5MM, 2.0MM SYSTEMJEY1995-09-28
518011820957828K951510ACE BONE SCREW TACKING KITDZL1995-08-25
518011509044802K951392MINIBONEPLATE SYSTEMJEY1995-05-05
303541623203733K950399RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROLJJY1995-02-22
303541178268033K946224CERTAIN(R) ELITE LEVEL 1, 2 AND 3JJS1995-01-30
303542036506138K944691ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR IIGGN1995-03-15
303541666247673K943754BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCTJJY1994-09-14
300101480980424K942938CROSSVENT-4 VENTILATORCBK1995-09-19
282672034954231K941245POLY-MEDICS HEAT PACKIMD1994-05-02
303541134643737K934907860 MEASURMENT SYSTEMCHL1994-01-03
300101603574584K925982BMD AIR/OXYGEN BLENDERBZR1993-10-07
282671785538746K924935HARD TISSUE REPLACE(HTR(R))-PATIENT-MATCH IMPLANTKKY1993-09-02
282671605238705K922741LORENZ 1.0 MM SYSTEMJEY1992-12-23
769041069303417K920626MODEL ELI 200 ELECTROCARDIOGRAPHLOS1992-09-04
769041202599285K913523AUTO. OSCILLOMETRIC DIGITAL BLOOD PRESS. MONITORDXN1991-11-06
303541664572031K913133CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)JJY1991-09-27
303541713977713K911755CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSEJJY1991-05-22
282671431612711K910038LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEMJEY1991-02-20
319581214571502K905164TUBE DECLOGGERKNT1991-02-13
313311890319202K901054BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDELSR1990-04-05
282671492884083K896667LORENZ STENTFWN1990-02-22
313311180433683K894626
313311574934797K894625CHLAMYDIA (LGV-1)LKI1989-08-15
313311875981357K894624MUMPS VIRUSGRA1989-10-16
313311950275429K894623RESPIRATORY SYNCYTIAL VIRUSLKT1989-10-16
313311138373074K894622VARICELLA ZOSTER VIRUSGQW1989-10-24
313311683286528K893240BION EBV-M (VCA) TEST SYSTEMLJN1989-07-14
313311303462728K891785BION EBV-G (VCA) TEST SYSTEMJRY1989-08-31
313311897228089K890616BION DIRECT IDENTIFICATION CONTROL SLIDELJG1989-02-17
135061113287089K890360GREER DERMAPIK SYSTEMSCL1989-06-23
303541189423436K882481HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/IIGGN1988-08-30
313311890589838K881261BION HSV1-G OR HSV2-G TEST SYSTEMGQO1988-06-07
303541864053111K880710PROTEIN BASE ISE CONTROLJJR1988-03-24
313311041279361K880679BION CMV-G TEST SYSTEMGQH1988-06-03
303541552225949K880447MULTI-FUNCTION BLOOD GAS CONTROLJJY1988-05-27
303541505208343K874408MULTI-FUNCTION BLOOD GAS CONTROLJJS1987-12-14
313311657927117K872845BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUMDHN1987-08-17
300101232633412K871336M-1 PRESSURE MONITORCAP1987-06-05
300101715719466K871139M-10 VENTILATION MONITORCAP1987-04-21
303541239946332K870036BAYER HEALTHCARE RAPIDQC PLUSJJS1987-01-14
537392030736756K863734STEINMANN(THREADED/CALIBRATED),KNOWLES&HOGIE PINSHTY1986-10-20
769041127065323K855127AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #90202DXN1986-08-14
282671013077894K854886WUERZBURG TITANIUM MINI BONE PLATES & BONE SCREWSJEY1986-01-21
303541611715120K853776MSI-HB HEMOGLOBIN CONTROLJPK1985-09-19
303542051178708K841783BLOOD GAS CONTROL, LEVEL I(ACIDOSISJJS1984-06-14
303541895355608K833146AQUEOUS BLOOD GAS CONTROLJJS1983-11-28
303541687164491K832028CERTAIN HB CO-OXIMETER CONTROLJJS1983-07-18
282671641729592K831005WIRE & STEINMAN PINSHTY1983-05-18
3511961264102446K253524Adaptos®Fuse Bone GraftMQV2026-02-17
281911998574796K250706Passeo-35 Xeo Peripheral Dilatation Catheter; Passeo-18 Peripheral Dilatation Catheters; Passeo-14 Peripheral Dilatation Catheter; Oscar Peripheral Multifunctional Catheter System; Pantera Pro Percutaneous Transluminal Coronary Angioplasty Catheter; Pantera LEO Percutaneous Transluminal Coronary Angioplasty (PTCA) CatheterLIT2025-04-04
518011117772777K243521Conical Ti Base abutmentsNHA2025-05-01
282671429951901K241709Pectus Blu Support Bar SystemHRS2024-09-19
282671671289857K241282RibFix Titan™ Fixation SystemHRS2024-08-19
281911336713106K240787Selectra 3D Lead Delivery System (443624-443629, 451789-451791); Selectra Slitter Tool (383119); Selectra Accessory Kit (375518)DQY2024-09-12
518011420773923K240531SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank AbutmentNHA2024-07-30
518011074344093K240187Tapered Pro Conical Implant SystemDZE2024-06-05
281911437751083K230375BIOMONITOR IVMXD2023-05-19
518011923539343K223697MRI compatibility for existing BioHorizons dental implants and abutmentsDZE2023-10-13
282671647707006K2231992.1 x 255mm Drill, 22mm StopHBE2022-11-15
281911382647764K222037Selectra Lead Implantation SystemDQY2022-07-19
281911775582339K221856BIOMONITOR IIIm, BIOMONITOR IIIMXD2022-07-27

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DZE382024-06-05
NBW342017-08-16
HRS302024-09-19
JEY232021-08-05
DXN202020-06-18
JJY192003-08-28
CGA182014-06-30
JJX182013-05-31
NHA152025-05-01
JJS122000-11-30
DQY62024-09-12
MXD62023-05-19
HWC52015-05-26
DPS52012-08-02
DZL52002-08-28
DQX42009-07-07
LFR42005-04-27
HBE32022-11-15
IYE32016-03-08
QSY32013-07-09
GGN32013-07-03
CHL32006-09-15
GLK32002-06-24
DTD32001-01-18
LOS31998-03-12
MQV22026-02-17
LIT22025-04-04
DRF22021-10-15
KNT22018-10-24
CBK22018-07-20
GEI22014-07-31
OSL22010-10-01
MRM22006-08-10
MLO22005-09-26
DHN22004-11-19
GXP22002-12-04
MWJ22002-06-27
MQN22002-02-22
MBI22001-11-16
KLE21999-11-15

NDC#

Fludeoxyglucose

Biomedical Research Foundation of Northwest Louisiana

Fludeoxyglucose F-18

Ammonia N 13

Biomedical Research Foundation of Northwest Louisiana

Ammonia N-13

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

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

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

Melatonin

BioActive Nutritional, Inc.

Melatonin

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 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...

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...

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 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...

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...

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...

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...

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PMN#

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Applications#

761164

BIOVERATIV THERAPEUTICS INC

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