FDA.reportPublic FDA data

STRYKER CORP.

Matched from indexed company URL: Stryker-Corp

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18117551811755STRYKER CORP.1Y2026-01-014100 EAST MILHAM AVE. KALAMAZOO MI US 49001

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07613327056952SERFAS Energy - 90-S, Suction Probe, Non-bendable, Max Cut Level 11+1(866)624-4422xx@xx.xx
07613327056976SERFAS Energy - 90-S XL Probe, Suction, Non-bendable, Max Cut Level 11+1(866)624-4422xx@xx.xx
07613327057027SERFAS Energy - 90-S Max, Suction Probe, Non-bendable, Max Cut Level 11+1(866)624-4422xx@xx.xx
07613327057034SERFAS Energy - 90-S Cruise, Suction Probe, Non-bendable, Max Cut Level 1+1(866)624-4422xx@xx.xx
07613327057041SERFAS Energy - 90-S Accelerator, Suction Probe, Non-bendable, Max Cut Level 11+1(866)624-4422xx@xx.xx
07613327058048CrossFlow - Integrated Arthroscopy Pump+1(866)624-4422xx@xx.xx
07613327294606NanoTack - NANOTACK TT SUTURE ANCHOR, 1.4MM WITH 1.2MM XBRAID TT+1(866)624-4422xx@xx.xx
07613327298642Sonopet iQ - Wireless FP Receiver for 5500008000+0018002533210Inst.Stryker.cs@Stryker.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
37761520326223K994053STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULEFYA1999-12-20
37762054233239K993148STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGAFYA1999-10-15
37761198332413K992931NON-STICK BIPOLAR FORCEPSGEI1999-11-17
37761774782370K992462OSTEONICS UNIVERSAL DISTAL CEMENT PLUGLZN1999-08-13
37761504761345K991703STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEMGCJ1999-05-27
37761741037233K991696STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEMDZI1999-10-25
37761396996444K990038HUMMER TRAK SYSTEMERL1999-02-19
37761149328640K982212VERITAS BIPOLAR, INSULATED, 0.5MM TIP, MODEL N301-005 VERITAS BIPOLAR, INSULATED 1.0MM TIP MODEL N301-010GEI1998-12-02
37762004771592K972584STRYKER HUMMER II MICRODEBRIDER SYSTEMERL1997-10-01
37761579776200K972367STRYKER SYSTEM 4000 HEAVY DUTY BATTERY POWERED EQUIPMENTKIJ1997-09-04
37761277198517K955599STRYKER FEMORAL CANAL SPONGE & ACETABULUM SPONGEGDY1996-02-22
37761080874024K952681STRYKER HUMMER II MICRODEBRIDER SYSTEMERL1995-07-20
37761546349394K952038CLEAN-CUFFKCY1995-07-11
37761597699193K951985PRECISION BIPOLAR COAGULATORGEI1995-05-23
37761997153776K944393STRYKER STERI-SHIELD SURGICAL APPARELFYA1995-08-28
37761572945991K943589STRYKER TOTAL PERFORMANCE SYSTEMHWE1994-12-15
37761757324633K943569STRYKER TOTAL PERFORMANCE SYSTEMERL1995-01-09
37761497228030K94354175K STAIGHT DRILLHBE1995-05-18
37761947854556K943540SURGICAL CUTTING BURSDZJ1994-11-30
37761035746617K943323STRYKER SURGICAL INSTRUMENTS AND ACCESSORIESHRX1994-11-28
37761285527830K942956SURGICAL INSTRUMENTS AND ACCESSORIESHWE1994-09-23
37761720862681K941605STRYKER FEMORAL CANAL BRUSH, ACETABULAR BRUSHLXH1994-08-05
37761936682938K940615ACCUTESTKCY1995-05-19
37761613540198K931847BIO-PREP CEMENT RESTRICTORLZN1994-06-28
37762035789555K924373ACCUFLATE ACCESSORIE CART W/IV POLE AND CLAMPBZN1992-11-25
37761357092877K924273ACCUFLATEKCY1993-01-12
37761802209634K921950SURGICAL DYNAMICS DISCOGRAPHY SYSTEMFMI1993-06-07
37761747540583K912190STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYSTJDZ1991-08-29
37761093391162K910512ACCUFLATEKCY1991-02-19
37761963638678K896541MALIS BIPOLAR ELECTROSURGICAL SYSTEM CMC-IIIGEI1990-01-29
37761790886768K890014DISPOSABLE COLOR-CUFFSKCY1989-01-24
37761735174846K883485STRYKER PRESSURE MONITOR SYSTEMFTY1988-09-13
37761911946742K881913PROTECTO-SHIELDFXX1988-07-08
37761770904264K863447STRYKER ORTHOPOWER 90 & ORTHOPOWER 90 SYSTEM IIGET1986-09-29
37761441301220K844214COMPARTMENT SYNDROME PRESSURE MONITOR SYSLXC1985-04-04
37761254524702K191049Stryker MIS and Footed AttachmentsHBE2019-06-18
37761262941126K190172Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsHBE2019-06-14
37761394685657K190070Sonopet iQ Ultrasonic Aspirator SystemLFL2019-04-11
37761139135309K182354SafeAir Telescopic Smoke PencilGEI2018-12-14
37761567233772K182224SafeAir Smoke Evacuator compactFYD2019-02-07
37761075490130K181752Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)HRX2018-12-21
37761252313397K180327Stryker iVAS 13g Bone Biopsy KitKNW2018-02-26
37762022530595K172558iVAS 8g Bone Biopsy Kit, iVAS 11g Bone Biopsy Kit, iVAS 10g Bone Biopsy KitKNW2017-10-05
37761604764313K172367Stryker Integrated Bipolar Cord and Tubing SetsGEI2017-08-22
37761047482480K172116Stryker iVAS Elite Inflatable Vertebral Augmentation System (Stryker iVAS Elite Balloon Catheter)HRX2018-01-25
37761456440521K171840Stryker Consolidated Operating Room Equipment (CORE) 2 ConsoleERL2017-09-15
37761453524752K170242MultiGen™ 2 RF Generator SystemGXD2017-05-25
37761379241745K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonHRX2016-11-01
37761663537658K161514Precision Thin Reciprocating Blade, 0.010in.EQJ2017-01-17
37761196466712K160693Neptune E-SEP Smoke Evacuation PencilGEI2016-04-13
37761091841389K153679Stryker Neptune E-SEP Smoke Evacuation PencilGEI2016-01-22
37761314670529K153407Stryker Neptune 3 Waste Management SystemJCX2016-04-25
37761677604780K152641Pi Drive Plus Motor, ExtenderERL2015-11-20
37761666067726K151125AVAflex Vertebral Balloon SystemHRX2015-11-24
37761889157451K150801Stryker Maestro Air MotorsHBB2015-05-22
37761397622904K150582Vertaplex® High Viscosity (HV) Radiopaque Bone CementNDN2015-06-12
37761712707942K150523AVAmax Vertebral BalloonHRX2015-10-29
37761707280989K143540Stryker MIS Attachments and Cutting AccessoriesHBE2015-05-01
37761411259336K143399Stryker Footed Attachments and Cutting AccessoriesHBE2015-05-08
37761779407819K143320Stryker Elite Attachments, Stryker Heavy Duty (HD) AttachmentsHBE2015-04-23
37761924428706K143145SafeAir Smoke PencilGEI2014-12-04
37761346519799K142538LiNA SafeAir Smoke PencilGEI2014-10-06
37761564125298K141935STRYKER S2 DRILLERL2014-09-26
37761411244268K141816HEMOPORELYA2014-10-23
37761297437362K141673IVAS 8 GAUGE BONE BIOPSY KITKNW2014-09-04
37761679748281K141423NASOPORE-FDLYA2014-08-07
37761440294765K141095STRYKER STERI-SHIELD FLYTE HYBRID TOGASFYA2014-08-26
37761076490000K140588FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENSFXY2014-06-26
37761885844819K132671STRYKER NEPTUNE 2 WASTE MANAGMENT SYSTEMJCX2013-12-20
37761349597158K131824AVAFLEX VERTEBRAL BALLOON SYSTEMHRX2013-10-03
37761064649947K131820AVAMAX VERTEBRAL BALLOON SYSTEM, 8G, AVAMAX VERTEBRAL BALLOON SYSTEM, 10G, AVAMAX VERTEBRAL BALLOON SYSTEM, 11GHRX2013-10-04
37761368432924K130430IVAS 10MM AND 15MM BALLOON CATHETERHRX2013-05-23
37761989811180K123942STRYKER IVAS BALLOON CATHETERNDN2013-04-03
37761187776774K123178STRYKER VENOM ELECTRODES AND CANNULAEGXI2013-03-28
37761722894623K121664T4/T5 HYTREL TOGASFYA2014-03-10
37761639891299K121426AYNERGETICS DISPOSABLE SPETZLER-MALIS STANDARD BIPOLAR FORCEPSGEI2012-07-10
37761067286881K120454SAFEAIR SMOKE PENCIL,GEI2012-12-07
37761787772737K113477IVAS 20MM (10 GAUGE) BALLOON CATHETERNDN2012-01-06
37761995857065K113154IVAS BALLOON CATHETERNDN2012-01-24
37761486084126K112593STYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMERL2012-05-01
37761928325737K110924DISPOSABLE SPETZLER-MALIS DUAL IRRIGATING BIPOLAR FORCEPSGEI2011-12-07
37761562271095K103807IVAS 2-10MM (10 GUAGE) BALLON CATHETERNDN2011-06-28
37761157907198K093419IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVASNDN2010-03-18
37761789058091K073633STRYKER ESSX MICRODEBRIDER SYSTEMERL2008-08-26
37761522523303K073017STRYKER STRI-SHIELD FLYTE TOGASFYA2007-11-30
37761898111945K072133AVAFLEX VERTEBRAL AUGMENTATION NEEDLENDN2007-11-20
37761073429262K072118STRYKER VERTAPLEX RADIOPAQUE BONE CEMENTNDN2007-12-07
37761993631207K071482STRYKER RF MULTI-LESION GENERATOR, MODEL 0406-900-000GXD2007-12-20
37761439279749K070715NASOPORE EARNHB2007-05-07
37761709721538K070091COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208KNW2007-04-18
37762016736586K070078STRYKER T4 HYTREL TOGAFYA2007-02-02
37761384305569K063489STRYKER INTRADISCAL RF GENERATORGXD2007-05-23
37761988173542K063480STRYKER RF INTRADISCAL ADAPTOR, MODEL 406-750GEI2007-05-22
37761875947578K063005STRYKER T6 HOODS AND TOGASFYA2007-03-23
37761287478500K061835STRYKER SILVERGLIDE BIPOLAR FORCEPS REUSABLE CABLE; DISPOSABLE CABLEGEI2006-09-08
37761836257825K061725STRYKER ARIA PNEUMATIC SYSTEMHBB2006-10-26
37761437443341K061660STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLEGEI2006-10-10
37762010736089K061108STRYKER AUTO IRRIGATION SYSTEMFRN2007-02-02
37761391702078K060997SNAP II EEG MONITOROLW2006-06-15
37761575875644K060076SURGICOUNT SAFETY-SPONGE SYSTEMLWH2006-03-14
37761645387996K060061STRYKER INJECTABLE CEMENTMQV2006-03-01
37761426519072K052099NASOPORE NASAL DRESSING, MODEL NDOX-YYY/ZZLYA2005-11-21
37761705053235K050753STRYKER DISCMONITORFMF2005-05-18
37761323603216K050364MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEMGEI2005-03-09
37761260959751K043518RADIOPAQUE BONE CEMENTNDN2005-05-11
37761478225856K043442STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAEGXI2005-05-31
37761882416215K042604VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTSGEI2004-10-22
37761201857593K041754STRYKER MAESTRO SYSTEMHBB2004-09-07
37762043094018K040369STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMDZJ2004-04-01
37761486888557K040300STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE)ERL2004-03-03
37761628317396K033499MALIS IRRIGATION MODULE 1000GEI2003-11-28
37761752329962K032945SIMPLEX XLOD2004-05-25
37761855628271K032943STRYKER VERTEBRAL BODY AND BONE BIOPSY KITS, STRYKER CAPTURE BODY AND BONE BIOSPSY KITSKNW2003-12-17
37761068232103K032601STRYKER INTERVENTIONAL PAIN RF GENERATORGXD2004-04-01
37761495763128K032473DEKOMPRESSOR PERCUTANEOUS DISCECTOMY PROBEHRX2003-11-07
37761676265254K032406STRYKER RF ELECTRODES AND CANNULAEGXI2004-04-01
37761435348303K032303STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEMHBE2004-01-16
37761267565096K032117STRYKER TOTAL PERFORMANCE (TPS) SYSTEMDZI2003-08-08
37761433921328K032117STRYKER TOTAL PERFORMANCE (TPS) SYSTEMDZI2003-08-08
37761441536314K022162STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGAFYA2002-08-01

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI192018-12-14
HRX112018-12-21
ERL112017-09-15
NDN92015-06-12
FYA92014-08-26
HBE72019-06-18
KNW52018-02-26
KCY51995-07-11
GXD42017-05-25
LFL32019-04-11
FYD32019-02-07
HBB32015-05-22
LYA32014-10-23
GXI32013-03-28
DZI32003-08-08
JCX22016-04-25
DZJ22004-04-01
LZN21999-08-13
HWE21994-12-15
EQJ12017-01-17
FXY12014-06-26
NHB12007-05-07
FRN12007-02-02
OLW12006-06-15
LWH12006-03-14
MQV12006-03-01
FMF12005-05-18
LOD12004-05-25
LYU12001-06-22
GCJ11999-05-27
KIJ11997-09-04
GDY11996-02-22
LXH11994-08-05
FMI11993-06-07
BZN11992-11-25
JDZ11991-08-29
FTY11988-09-13
FXX11988-07-08
GET11986-09-29
LXC11985-04-04

PMA#

54 records. Showing 1-40. Next

PMN#

200 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next