FDA.reportPublic FDA data

ABCORP

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10648513000135139ABATEMENT TECHNOLOGIES, INC.1Y2026-01-01605 Satellite Blvd NW Ste 300 SUWANEE GA US 30024
12157091215709ABCORP1N2026-01-01225 Rivermoor St Boston MA US 02132
12206481220648ABIOMED, INC.1N2026-01-0122 Cherry Hill Dr DANVERS MA US 01923
12213591221359Abbott Diagnostics Scarborough, Inc.1N2026-01-0110 Southgate Rd Scarborough ME US 04074
14159391415939ABBOTT LABORATORIES1N2026-01-01100 ABBOTT PARK RD. Abbott Park IL US 60064
14519141451914ABBOTT LABORATORIES1Y2026-01-01U.S. 41/MARTIN LUTHER KING DR. North Chicago IL US 60064
15258381525838ABRASIVE TECHNOLOGY, LLC1Y2026-01-018400 Green Meadows Drive N. LEWIS CENTER OH US 43035
16274871627487Abbott Medical1N2026-01-016901 Preston Rd PLANO TX US 75024
16286641628664ABBOTT LABORATORIES1N2026-01-011921 Hurd Dr IRVING TX US 75038
20178652017865ABBOTT MEDICAL1N2026-01-0115900 Valley View Court Sylmar CA US 91342
20241682024168ABBOTT VASCULAR1Y2026-01-0126531 YNEZ RD. Temecula CA US 92591
20857213000219565ABBA OPTICAL1Y2026-01-016396 Roland St Buena Park CA US 90621
21351473005334138Abbott Medical1N2026-01-015050 NATHAN LANE NORTH Plymouth MN US 55442
22455782245578ABBOTT POINT OF CARE INC.1Y2026-01-01400 College Road East Princeton NJ US 08540
26300312630031ABBOTT LABORATORIES (PUERTO RICO) INCORPORATED1Y2026-01-019615 Ave Los Romeros Ste 700 San Juan PR US 00926
26486122648612Abbott Medical1N2026-01-01LOT 20 B Street Caguas West Industrial Park Caguas PR US 00725
29165472916547ABB Optical Group LLC.1N2026-01-013901 Ne 33rd Ter Ste E Kansas City MO US 64117
29190692919069ABBOTT LABORATORIES1N2026-01-01647 Almanor Ave. Sunnyvale CA US 94085
29395613004635528ABBOTT VASCULAR1N2026-01-013200 Lakeside Dr SANTA CLARA CA US 95054
29396932939693ABAXIS, INC.1N2026-01-013240 WHIPPLE RD. UNION CITY CA US 94587
29543233002803444ABBOTT DIABETES CARE INC.1Y2026-01-011360 SOUTH LOOP RD. ALAMEDA CA US 94502
80439913004017406ABIGO MEDICAL AB1N2026-01-01MOLNDALS BRO 2 MOLNDAL Vastra Gotaland SE 431 31
96803043002807657Abrar Solatch1N2026-01-01503 W Pleasant Grove Road Westchester PA US 19382
10002024621000202462AB MEDICA GROUP S. A.1N2026-01-01Calle Jerico 10 Bis Interior Barcelona ES 08035
30001351383000135138ABATEMENT TECHNOLOGIES LIMITED1N2026-01-011481 Harber Court FORT ERIE Ontario CA L2A 0G3

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2049411864801312P970030TORONTO SPV VALVELWR1997-11-04
21491971992102P970020MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMSMAF1997-10-02
21591971992102P970020MULTI-LINK ULTRA/ ZETA CORONARY STENT SYSTEMSMAF1997-10-02
59311609226794P970013MICRONY PACEMAKERSLWO2000-12-21
21491867642010P960043PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEMMGB1997-04-30
21591867642010P960043PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEMMGB1997-04-30
59311949371366P960030PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADSNVN1998-01-29
59311615224818P960013TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADSNVN1997-06-20
59311405123025P950022TVL(TM) LEAD SYSTEMLWS1996-05-10
3469671497123612P940035NMP22 BladderChek TestNAH1996-07-02
59311461275087P910023CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEMLWS1993-04-30
15141655575937P900023ABIOMED BVS(R) 5000 BI-VENTRICULAR SUPPORT SYSTEMDSQ1992-11-20
59311346726378P880086ACCENT, IDENTITY, VERITY, VICTORY AND ZEPHYR PACEMAKERSDXY1989-08-21
59311089540043P880006SENSOLOG MODEL 703 PULSE GENERATOR & P700 PROGRAMMDXY1989-02-28
1281901240131723P820051
59271427691137P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
2049411427691137P810002BILEAFLET-CENTER OPENING CARDIAC VALVELWQ1982-12-17
2049411072781342P240042Tendyne Transcatheter Mitral Valve SystemNPU2025-05-23
21491961512206P230036Esprit™ BTK Everolimus Eluting Resorbable Scaffold SystemNXW2024-04-26
21591961512206P230036Esprit™ BTK Everolimus Eluting Resorbable Scaffold SystemNXW2024-04-26
2049411118222661P230007TriClip G4 SystemNPS2024-04-01
2049411772560416P200049Amplatzer™ Amulet™ Left Atrial Appendage OccluderNGV2021-08-14
2049411317995609P190023Portico Transcatheter Aortic Valve Implantation SystemNPT2021-09-17
15141597260964P170011Impella RP SystemPYX2017-09-20
20891297052832P160030Freestyle Libre Flash Glucose Monitoring SystemPZE2017-09-27
59311957404550P150035Aveir VR Leadless SystemPNJ2022-03-31
21491457511207P150023ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEMPNY2016-07-05
21591457511207P150023ABSORB GT1 BIORESORBABLE VASCULAR SCAFFOLD (BVS) SYSTEMPNY2016-07-05
20891886736038P150021FREESTYLE LIBRE PRO FLASH GLUCOSE MONITORING SYSTEMMDS2016-09-23
59381478505081P150004Axium Neurostimulator SystemPMP2016-02-11
59312051987943P140033Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer SoftwareLWP2017-01-31
59381326517770P140009BRIO NEUROSTIMULATION SYSTEMMHY2015-06-12
15141655437629P140003IMPELLA 2.5 SystemOZD2015-03-23
2049411148803325P120021AMPLATZER PFO OCCLUDERMLV2016-10-28
21491067542151P120020SUPERA PERIPHERAL STENT SYSTEMNIP2014-03-28
21591067542151P120020SUPERA PERIPHERAL STENT SYSTEMNIP2014-03-28
21491792004051P110043OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEMNIO2012-07-31
21591792004051P110043OMNILINK ELITE PERIPHERAL BALLOON-EXPANDABLE STENT SYSTEMNIO2012-07-31
21491309805090P110028ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEMNIO2012-02-22
21591309805090P110028ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEMNIO2012-02-22
21491542162583P110019Xience Skypoint Everolimus Eluting Coronary Stent SystemNIQ2011-11-01
21591542162583P110019Xience Skypoint Everolimus Eluting Coronary Stent SystemNIQ2011-11-01
21491469892557P110001RX HERCULINK ELITE RENAL STENT SYSTEMNIN2011-07-20
21591469892557P110001RX HERCULINK ELITE RENAL STENT SYSTEMNIN2011-07-20
2049411259362317P100029ST JUDE MEDICAL TRIFECTA VALVELWR2011-04-20
21491128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
21591128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
2049411128100614P100009MITRACLIP DELIVERY SYSTEMNKM2013-10-24
21491727611267P070015XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMSNIQ2008-07-02
21591727611267P070015XIENCE AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMSNIQ2008-07-02
21491559811470P050007STARCLOSE VASCULAR CLOSURE SYSTEMMGB2005-12-21
21591559811470P050007STARCLOSE VASCULAR CLOSURE SYSTEMMGB2005-12-21
2049411948089994P040040AMPLATZER MUSCULAR VSD OCCLUDERMLV2007-09-07
21491681222287P040038XACT CAROTID STENT SYSTEMNIM2005-09-06
21591681222287P040038XACT CAROTID STENT SYSTEMNIM2005-09-06
2049411469465816P040021SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVELWR2005-08-05
21491479612281P040012ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEMNIM2004-08-30
21591479612281P040012ACCULINK CAROTID STENT SYSTEM AND RX ACCULINK CAROTID STENT SYSTEMNIM2004-08-30
59311599943823P030054ST JUDE MEDICAL EPIC HF SYSTEMNIK2004-06-30
59311539821199P030035ANTHEM AND FRONTIER II CRT-P'SNKE2004-05-13
21491963635576P020047MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMSMAF2003-07-16
21591963635576P020047MULTI-LINK VISION/MINI/8 CORONARY STENT SYSTEMSMAF2003-07-16
2049411437057228P020024AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEMMAE2003-05-14
59311213468741P010032GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMSLGW2001-11-21
59381213468741P010032GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMSLGW2001-11-21
2049411720702331P000039THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEMMLV2001-12-05
423421273158649K993211PICCOLO SODIUM TEST SYSTEMJGS1999-10-25
59381772202268K992946RENEW RECEIVERGZB1999-09-24
1281901404294023K992466OCU-FLEX-38 KERATOCONUS (POLYMACON) SOFT CONTACT LENS FOR DAILY WEARLPL1999-10-04
21491233166198K992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIREDQX1999-10-28
21591233166198K992169ACS HI-TORQUE CROSS-IT 400XT GUIDE WIREDQX1999-10-28
423421030602779K992140PICCOLO METLYTE 7 REAGENT DISCJLB1999-08-26
20871470727330K991605CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTIONGKZ1999-07-09
21491589735738K991102COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331DTL1999-06-09
21591589735738K991102COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331DTL1999-06-09
21491208749907K990639ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.DQX1999-03-25
21591208749907K990639ACS HI-TORQUE CROSS IT 100XT, 200XT AND 300XT GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING.DQX1999-03-25
59381135856364K990469LAMITRODE LEADSGZB1999-06-03
21491267300283K984394ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATINGDQX1999-03-08
21591267300283K984394ACS HI-TORQUE WIGGLE GUIDE WIRE WITH MICROGLIDE COATINGDQX1999-03-08
179331488390354K984116HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400CFRF1999-06-24
179341488390354K984116HEPA-CARE AIR CLEANER AMERICAN AIR FILTER AIR FILTRATION SYSTEM MODELS HC800F, HFS800F, HC800C/ HFS800C, HC400C/HFS400CFRF1999-06-24
21491757061627K982876HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282DQX1998-11-10
21591757061627K982876HI-TORQUE STEELCORE 18 GUIDE WIRE MODEL NUMBERS 1003280, 1003281, 1003282DQX1998-11-10
21491210905110K981381ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1DQX1998-07-15
21591210905110K981381ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING PRODUCT FAMILY MODELS 1003211H,1003212HJ,1003213H,1DQX1998-07-15
20871331970531K981342ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAYGKZ1998-06-29
21491576736442K980119ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIREDQX1998-03-20
21591576736442K980119ACS HI-TORQUE WHOLEY SUPRA CORE GUIDE WIREDQX1998-03-20
21491412691795K974773HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILICDQX1998-03-13
21591412691795K974773HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILICDQX1998-03-13
20921950296043K972868TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROLJJY1997-08-28
21491887303636K972142ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATINGDQX1997-08-25
21591887303636K972142ACS HI-TORQUE ALL STAR 0.014 GUIDE WIRE WITH MICROGLIDE COATINGDQX1997-08-25
21492053257521K971815ASC BALANCE MIDDLEWEIGHT GUIDE WIREDQX1997-07-09
21592053257521K971815ASC BALANCE MIDDLEWEIGHT GUIDE WIREDQX1997-07-09
21491439277137K963702ACS HI-TORQUE IRON MAN GUIDE WIREDQX1997-01-22
21591439277137K963702ACS HI-TORQUE IRON MAN GUIDE WIREDQX1997-01-22
21491725321618K962495INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)MAV1996-09-12
21591725321618K962495INDEFLATOR PLUS 30/PLUS 30 PRIORITY PACK9WITH THE.096 OR.115 ROTATING HEMOSTATIC VALVE)MAV1996-09-12
21491879529914K961471INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)MAV1996-05-08
21591879529914K961471INDEFLATOR 20/30 INFLATION DEVICE AND 20/30 PRIORITY PACK (WITH THE .096 OR .115 ROTATING HEMOSTATIC VALVE)MAV1996-05-08
59382023801547K960728ONE STEP CONNECT LEADS (QUATTRODE, OCTRODE, CERVITRODE)GZB1996-05-22
3469671137616619K960712BINAX STREP A TESTGTZ1996-03-22
1281901176353202K960291TINTED OCU-FLEX 53 (OCCUFILCON B) SOFT HYDROPHILIC CONTACT LENSLPL1996-03-25
21491748988175K950752ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITSDQX1995-05-15
21591748988175K950752ACS TORQUE DEVICE, ACS GUIDE WIRE INTRODUCER, ACS GUIDE WIRE ACCESSORY KITSDQX1995-05-15
423421389889655K950164PICCOLO(TM) PRIMARY HEALTH PANEL REAGENT ROTORCHH1995-04-13
21491469853050K950156ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIREDQX1995-04-05
21591469853050K950156ACS HI-TORQUE EXTRA S'PORT(TM) GUIDE WIREDQX1995-04-05
59311921274733K950140IS-1/QUADRIPOLAR TERMINAL CAP, PART NUMBER 6011069DTD1995-04-06
423421337321834K942782PICCOLO(TM)JJG1995-03-13
21491449155535K942066ACS HI-TORQUE EXTRA S'PORT GUIDE WIREDQX1994-07-18
21591449155535K942066ACS HI-TORQUE EXTRA S'PORT GUIDE WIREDQX1994-07-18
1281901082363589K941998OCU-FLEX-38 (POLYMACON)LPL1994-10-13
59381780816653K941342PAIN DOCGZB1995-10-13

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQX982025-10-03
GZB382014-05-02
DQY372026-07-02
NBW222017-09-27
LOX182022-06-30
MXC152023-05-17
GKZ132025-02-20
LIT122026-02-13
NQQ112026-04-24
DYB112023-03-01
DRA92019-05-29
KRH92009-10-16
LPL92002-12-10
GXI62025-05-27
CGA62023-09-11
QLG62022-05-26
NTE62019-07-25
LDF62016-11-22
FGE62008-08-18
FRO52017-08-21
LFR52015-09-17
MAF52003-07-16
CHL42025-05-02
JGS42023-10-27
KRD42012-06-12
NIQ42011-11-01
MGB42005-12-21
DTL41999-06-09
MAV41996-09-12
QBJ32024-04-23
DQO32023-04-14
GXD32020-10-21
OCC32017-09-29
MLV32016-10-28
NKM32013-10-24
GLQ32011-12-22
DSA32010-04-02
DRB32009-04-01
LGW32001-11-21
MXD22025-12-18

NDC#

177 records. Showing 1-40. Next

PMA#

200 records. Showing 161-200. Previous

PMN#

200 records. Showing 1-40. Next

Applications#

200 records. Showing 1-40. Next