FDA.reportPublic FDA data

Bio

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
BIOMENDEX OY5N2026-01-01Korkeakoulunkatu 1 Tampere Pirkanmaa FI 33720
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
18243621824362BIOTEC, INC.1N2026-01-01652 EAST MAIN ST. ZEELAND MI US 49464
18250341825034BIOMET, INC.1Y2026-01-0156 E Bell Dr Po Box 587 WARSAW IN US 46581
18334701000115518BIOMEDIX WAI1N2026-01-018600 Shelby Court Chanhassen MN US 55317
18335061832656BIOPRO, INC.1Y2026-01-012929 Lapeer Rd PORT HURON MI US 48060

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
39461366094108P010014OXFORD(TM) MENISCAL UNICOMPARTMENTAL KNEE SYSTEMNRA2004-04-21
281911874963309P000009PHYLAX AV ICD SYSTEMMRM2000-09-29
39461241100863K994326ASCENT KNEE SYSTEMKWH2000-01-07
39461650632723K994184PLR SPLINED REVISION STEMLZO2000-02-15
39461577585115K994038MODULAR REACH HIPLPH1999-12-22
39462045415813K993956TITANIUM PEDIATRIC FEMORAL NAILHSB1999-12-20
39461626436159K993886EBI XFIX VISION FIXATION SYSTEMKTT1999-12-14
39461562905539K993649EBI XFIX DFS WRISTFIX SYSTEMKTT1999-11-19
39462013354644K993510MODIFIED BMP TROCHANTERIC PLATESHRS1999-11-16
518011308220832K993493THE AUTOTAC SYSTEMDZL2000-01-07
39461795944773K993465DEPUY ACE CALCANEAL PERI-ARTICULAR PLATEHRS2000-01-11
39461110631126K993159MAXIM KNEE SYSTEMJWH1999-10-14
39461632752208K993111ASCENT KNEE SYSTEMJWH1999-10-05
282671317338145K992961LORENZ SMALL FRAGMENT SYSTEMHRS1999-11-08
282671859980973K992952LORENZ DISTRACTION SYSTEMMQN1999-11-19
39461233707316K992899BIO-MODULAR SHOULDER OFFSET HUMERAL HEADSKWS1999-10-21
566771763583302K992838ADHERE CONDITIONER, ADHERE PRIMER, ADHERE LC ADHESIVE, ADHERE DC ADHERE DC ACTIVATOR, ADHERE CYLANATEKLE1999-11-15
39461922983824K992515EBI XFIX DFS OPTIROM ELBOW FIXATORKTT1999-08-17
39461654689651K992367EBI XFIX DYNAFIX SYSTEM HA COATED SCREWSHWC1999-09-23
282671472800172K992355LACTOSORB TRAUMA PLATING SYSTEMHRS1999-12-20
39461596278752K992355LACTOSORB TRAUMA PLATING SYSTEMHRS1999-12-20
39462024954188K992301REUNITE SCREWSHWC1999-09-01
39461544138925K992158LACTOSORB SHEETSJEY1999-08-20
282671684830220K992158LACTOSORB SHEETSJEY1999-08-20
430221188624785K992144BIOPRO RIMMED ACETABULAR COMPOMENTLZO1999-09-22
39461068456792K992119BIO-MODULAR SHOULDER SYSTEMKWS1999-09-13
39461821866250K992058BI-METRIC CCOCR HEAD/NECK REPLACEMENT SYSTEMJDI1999-07-01
39461999719050K991990TRI-POLAR SYSTEMKWY1999-09-10
39461008928096K991941EBI XFIX DFS RAIL SYSTEMKTT1999-08-19
39461429924188K991807TITANIUM LOW PROFILE SCREWSLPH1999-07-08
39461091166684K991806VHS SUPRACONDYLAR PLATE SYSTEMKTT1999-08-06
39461129819197K991763LACTOSORB HAND SYSTEMHRS1999-07-30
39461031188119K991649DEPUY ROCKWOOD CLAVICLE PINJDW1999-07-14
39461801357935K991428ASCENT KNEE SYSTEMJWH1999-05-21
39461425224317K991298BONE MULCH SCREW SYSTEMHWC1999-05-14
39461168462544K990830MALLORY/HEAD CALCAR REPLACEMENT WITH INTERLOCKING SLOTS BI-METRIC POROUS COLLARED STEM WITH INTERLOCKING SLOTSLPH2000-04-11
430221273069598K990821PROVIDENCE CUP SYSTEMJDI1999-04-29
39461511531225K990392DEPUY ACE SPIDER PLATEHRS1999-03-23
39461515916051K990291LACTOSORB BONE PINHTY1999-03-23
282671879130763K990290CRANIOFACIAL CALCIUM PHOSPHATE CERAMIC BONE FILLERGXP1999-11-18
518011844450069K990277O-RING ABUTMENTDZE1999-04-09
39461756435945K990120MODIFICATION OF DEPUY ACE TIMAX MEDIAL PILON PLATEHSB1999-02-01
39461838176444K990032MODULAR PROTUSIO CUPJDI1999-02-18
39461556062427K984458DEPUY ACE SPIDER PLATEHRS1998-12-31
39461800594641K984408130 MODIFIED INTEGRAL FEMORAL COMPONENTLPH1999-02-12
39461985899332K984390LACTOSORB PANELS AND FASTENERSHRS2000-08-07
39461944111078K984296LATERALIZED INTERGRAL POROUS PRIMARY FEMORAL COMPONENTLPH1999-02-18
303542046724335K984261SURESTEP BLOOD GLUCOSE MONITORING SYSTEMCGA1999-05-21
39461929114029K984209STAINLESS STEEL TAPER FOREMAN NAIL CANNULATED SCREW, STAINLESS STEEL CANNULATED SCREW, SHORT THREAD, STAINLESS STEEL PEDHWC1999-02-03
39461908906200K984054AGC V2 REVISION KNEE SYSTEMJWH1999-07-30
39461740273925K984028THE NEW BIO-MOORE ENDO HEADSKWL1999-01-19
39461875928523K983910ARTHRO-SURGIMAT-1500HRX1998-11-25
39461399677586K983853DEPUY ACE TIMAX META PLATEHRS1998-12-22
282671156603292K983728LORENZ IMF SCREWDZL1999-05-13
39461596900666K983710150MM COCR BIMETRIC HEAD/NECK REPLACEMENT HIP STEM- COLOR BUFF FINISHJDI1998-12-02
303541595964019K983475HEMOCHRON RESPONSEKQG1999-05-03
39462038164680K983265DEPUY ACE COMPOSITE LOCKING NUTHTN1998-10-26
39461668063198K983035CUSTOM FLANGED ACETABULAR COMPONENTLPH1998-11-23
39461847228255K982953TITANIUM INTRAMEDULLARY NAILS-VARIOUS STYLESHSB1998-10-21
39461213336108K982869ASCENT SYSTEMJWH1998-09-22
39461308984742K982545BMP CABLE SYSTEMJDQ1998-10-19
39461104430674K982497ARTHROTEK INTERFERENCE SCREWHWC1998-10-16
39461162269099K982367REACH HIP COMPONENTLPH1998-08-24
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
39461437423604K982095LACTOSORB MENISCAL REPAIR DEVICEMAI1999-01-27
39461760728559K981967WASHERLOC SCREW SYSTEM, LIGAMENT SCREW SYSTEM, NO-PROFILE BI-CORTICAL SCREW SYSTEM, CHANNEL LIGAMENT CLAMP, HECKMAN SCREMBI1998-07-17
39461293298888K981798LACTOSORB POP RIVETJDR1998-07-13
282671449754667K981789LORENZ PECTUS SUPPORT BAR STABILIZERHRS1998-07-13
39461726188136K981775DEPUY ACE TIMAX CALCANEAL PERI-ARTICULAR PLATEHRS1998-07-29
39461070140916K981483EBI DFS JOINT FIXATOR, MODEL 02800KTT1998-07-08
282671154749478K98107020-HOLE ADAPTATION PLATEJEY1998-05-20
282671581415731K980927LACTOSORB PANELS AND FASTENERSJEY1998-06-05
39461981331789K980927LACTOSORB PANELS AND FASTENERSJEY1998-06-05
39461940597226K980665REPICCI II UNICONDYLAR KNEE ALL POLY TIBIAL COMPONENTSHRY1998-05-20
282672031446665K980512LORENZ RECONSTRUCTION SYSTEM WITH MODULAR SCREWJEY1998-05-11
39462005344499K980428BIOMET BIAXIAL TOTAL ELBOWJDC1998-05-05
39461357699056K980370BIOSYMMETRIC PROXIMAL INTERPHALANGEAL JOINT FIXATORKTT1998-04-14
303541824569714K980178OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRYJJY1998-02-12
303541156237161K974822AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROLJJY1998-01-22
39461130470892K974781DEPUY ACE AIM(R) TITANIUM SUPRACONDYLAR NAILHSB1998-03-10
39461374710472K974558SALVAGE/ONOCOLOGY HIP AND TOTAL FEMUR SYSTEMJDI1998-03-04
282671229699384K974309LACTOSORB PANELSHRS1998-01-30
282671877518770K974136CRANIOFACIAL ANCHORSMBI1998-01-30
39462052631081K973775HARPOON SUTURE ANCHORSMBI1998-04-16
769041919396307K973403CARDIOSMART STLOS1998-03-12
282671188307185K973080SURGICAL VASCULAR CLAMPDXC1998-02-23
303541080628556K972868TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROLJJY1997-08-28
39461493802268K972860CURVTEK TSR SYSTEMHSZ1997-10-31
39461013120852K972629DEPUY AE TK2 HIP SCREW SYSTEMKTT1997-10-09
282671679758144K972420LORENZ PECTUS SUPPORT BARHRS1997-08-11
282671369293463K972322LORENZ 1.5 MM NEURO PACK/LORENZ 2.0 FT PLATESJEY1997-08-18
518011109251455K972313THE MAESTRO SYSTEMDZE1997-09-16
39461263397641K972183DEPUY ACE A.I.M. TITANIUM TIBIAL NAILHSB1997-08-26
282671876207441K972074SUCTION INSTRUMENTATIONGCX1997-07-25
39461640282774K971996MEDIVISION ARTHROSCOPHRX1997-07-31
39461289281681K971938REPICCI II UNICONDYLAR KNEEHRY1997-08-25
281911413560754K971930BK-N SEALING CAPDTD1997-08-14
39461608362543K971890RECOVERY PROTRUSIO CAGEJDI1997-08-07
39461537768154K971870LACTOSORB TRAUMA PLATING SYSTEMHRS1997-08-19
282671600712248K971870LACTOSORB TRAUMA PLATING SYSTEMHRS1997-08-19
39461076344651K971824REACH FEMORAL HIP COMPONENTLPH1997-12-04
39461444474741K971069TWIST-OFF (TM) SCREWHWC1997-07-09
303541975420511K970556SURESTEP PRO BLOOD GLUCOSE MONITORING SYSTEMCGA1997-05-12
39461485241148K970503DEPUY ACE TROCHANTERIC SIDE PLATEHRS1997-04-30
39461182374070K970501PEGGED ACETABULAR COMPONENTLPH1997-04-30
39461112933415K970290EBI X FIX DYNAFIX MINI EXTERNAL FIXATION SYSTEMKTT1997-04-01

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
HRS1012025-07-25
HWC592020-02-24
KTT542011-12-15
LPH502026-05-19
JDI472015-10-14
JWH452017-07-28
DZE382024-06-05
HSB352018-12-14
NBW342017-08-16
MBI292020-11-10
JEY252021-08-05
LZO212020-12-08
DXN202020-06-18
KWA202011-09-30
JJY192003-08-28
CGA182014-06-30
JJX182013-05-31
PHX172026-04-15
KRO162014-05-28
NHA152025-05-01
HTY152024-05-22
JDR132015-10-02
HRY122014-03-28
JJS122000-11-30
MBF112020-10-28
KWT102023-07-12
MBH102016-05-10
LXT102013-10-09
JDW92013-06-18
KWY82019-09-17
MBB72022-12-28
KWS72021-12-10
HRX72008-09-09
JEC71994-06-16
DQY62024-09-12
MXD62023-05-19
JDG62022-02-07
DZL62014-10-02
HSD62005-09-29
MQV52026-02-17

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#

200 records. Showing 1-40. Next

Applications#

761164

BIOVERATIV THERAPEUTICS INC

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