FDA.reportPublic FDA data

STRYKER EMEA Supply Chain Services

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30088373393008837339STRYKER EMEA Supply Chain Services1N2026-01-01Frans Maasweg 2 Venlo Limburg NL 5928 SB

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1962121799103106P180031Neuroform Atlas® Stent SystemQCA2019-05-16
1962121109464444P170024Surpass Streamline Flow DiverterOUT2018-07-13
1962121945695012K994155EXCELSIOR 1018 MICROCATHETERKRA2000-08-03
1962121600100300K993239STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXXHAW2000-01-18
1962121526317417K993045BARIATRIC LAPAROSCOPE, MODEL 367GCJ1999-10-27
1962121451159892K983557STRYKER WEDGE SUTURE ANCHORMBI1998-12-18
1962122024569217K982375STRYKER HIP ARTHOROSCOPY SETHRX1998-10-02
1962121565733190K973259K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS)OCZ1997-09-10
1962121869749412K963304STRYKER TEMPEST ORTHOPEDIC PUMPHRX1997-01-22
1962121804237555K962075HSW GMBH ARTHROSCOPEHRX1997-01-17
1962121997153776K944393STRYKER STERI-SHIELD SURGICAL APPARELFYA1995-08-28
1962121124621380K944025SURGICAL INSTRUMENT TRAYFSM1994-11-22
1962121487387748K943100STRYKER OPERATING LAPAROSCOPEHET1995-08-10
1962121802209634K921950SURGICAL DYNAMICS DISCOGRAPHY SYSTEMFMI1993-06-07
1962121299391249K910858STRYKER ARTHROSCOPIC INFUSION PUMPHRX1991-05-23
1962121610195813K910132STRYKER LAPAROSCOPEGCJ1991-02-21
1962121753492785K900332EM 1149 OPTIMIZE SCOTCHPLATE CONDUC ADHES DISP ELEGEI1990-02-13
1962121572066588K8333643M SCOTCHPLATE II DISPERSIVE ELECTRODEGEI1983-11-29
1962121304884165K260721Tornier Perform Advanced GlenoidKWS2026-07-22
1962121971236275K251971RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip PointerOLO2025-09-25
1962121306644220K242373Mako Shoulder Application (1.0)OLO2024-11-07
1962121004876062K242289Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped MicrocatheterQJP2025-03-21
1962121487777953K242243Target Detachable CoilsHCG2024-08-29
1962121936087384K241517Q Guidance System; Mako Spine System;OLO2024-08-27
1962121128574889K240662Spine Guidance Software (version 5.0); Xia 3/ Serrato Q Instruments; Everest Q Instruments; Mesa 2 Q Instruments; Q Pedicle Preparation Instruments; Q S2AI Drills; Q Handles; Consolidated Operating Room Equipment (CORE) 2 Console; Electric System 6 Dual Trigger Rotary HandpieceOLO2024-06-06
1962121614764511K233542Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance SystemOLO2024-03-14
1962121209780604K230045HipCheckQIH2023-09-29
1962121312287647K223767Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance SystemOLO2023-02-13
1962121013487395K223294SpineJack® Expansion KitNDN2022-12-20
1962121808149479K222533Target Tetra Detachable CoilsHCG2022-12-14
1962121318674077K221098Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation UnitPGW2022-07-12
1962121934523525K221074OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion DeviceGEI2022-09-16
1962121997889949K220593Spine Guidance Software, Stryker Q Guidance SystemOLO2022-05-27
1962121143870078K212194Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Navigation Instruments, Mayfield Base with Articulating Arm, and Navigated Biopsy Needle, Electromagnetic Navigation Instruments, Precision Targeting SystemHAW2023-02-16
1962121309099957K2112021688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K SinuscopesGWG2021-08-06
1962121755333410K202749ADAPT for Gamma3OLO2020-12-18
1962121832224252K202609Instrument Clamps ElectromagneticPGW2020-10-09
1962121322163314K201361PNEUMOCLEARHIF2020-07-29
1962121415553710K191102Precision S 4K SinuscopeEOB2019-09-06
1962121955730986K190843Synchro2 Support GuidewireMOF2019-05-01
1962121582053038K183470Precision Ideal Eyes ArthroscopesHRX2019-01-07
1962121063925495K183464AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm)NRY2019-03-13
1962121250772311K183463AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cmDQY2019-03-13
1962121524071038K183196Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask TrackerOLO2019-02-14
1962121139135309K182354SafeAir Telescopic Smoke PencilGEI2018-12-14
1962121891039727K181848ADAPT for Gamma3, Gamma3OLO2018-10-12
1962121047440689K173841AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cmNRY2018-03-18
1962121122575109K172433NICO BrainPathGZT2017-09-07
1962121165214150K172034Stryker Spine Navigation System with SpineMap 3D software application, OrthoLock, nGenius Spine Clamp, Navigated Drill Guide Set, Navigated Xia 3 Awl Tap, Navigated Xia 3 Serrato TapOLO2017-10-18
1962121386468920K171947SOLOASSIST IINAY2018-09-21
1962121021703777K171661Scopis Extended Instrument Set EMPGW2017-09-27
1962121536299428K170784PNEUMOCLEARHIF2017-05-15
1962121509252692K170329Basic, Dominant FlexQPB2017-03-24
1962121453524752K170242MultiGen™ 2 RF Generator SystemGXD2017-05-25
1962121389383527K163259AXS Offset Delivery Assist CatheterDQY2017-07-28
1962121301938601K162937Stryker OrthoMap Versatile Hip SystemOLO2017-02-23
1962121432931699K162929Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask TrackerHAW2017-02-22
1962121495104426K162341Stryker OrthoMap Precision Knee systemOLO2016-10-12
1962121701674757K161491Scopis Hybrid Navigation System EMPGW2017-02-09
1962121857476565K161429Target Detachable CoilsHCG2016-06-22
1962121196466712K160693Neptune E-SEP Smoke Evacuation PencilGEI2016-04-13
1962121091841389K153679Stryker Neptune E-SEP Smoke Evacuation PencilGEI2016-01-22
1962121762949219K153658Target Detachable CoilsHCG2016-05-19
1962121062556968K153240Styrker OrthoMap Express Knee SystemOLO2016-07-07
1962121041983666K152876LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CMDQY2016-01-08
1962122014806834K151667AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cmDQY2015-11-13
1962122038567068K151243STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit]FCS2015-08-20
1962121311084219K150134Basic, Dominant Flex, KV-6QPB2015-04-21
1962121729031426K142565Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped MicrocatheterDQY2014-11-14
1962121476266145K141941SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES DOLO2014-10-31
1962121440294765K141095STRYKER STERI-SHIELD FLYTE HYBRID TOGASFYA2014-08-26
1962121076490000K140588FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENSFXY2014-06-26
1962121896651938K131214CRANIAL MAP NEUROHAW2013-10-18
1962121390909597K130874STRYKER NAV3I PLATFORMHAW2013-09-27
1962121792247678K130123BASIC AND DOMINANT FLEX SUCTION PUMPSBTA2013-10-11
1962121179842344K123441STRYKER CROSSFLOW ARTHROSCOPY PUMPHRX2013-01-09
1962121305747323K123377TARGET DETACHABLE COILHCG2012-11-30
1962121340159645K122576TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANTMJN2013-01-11
1962121663328532K113778EXCELSIOR XT-27 MICROCATHETERDQY2012-04-20
1962121959311409K113297KNOTILUS ANCHOR SYSTEMMBI2012-03-02
1962121858470909K112671STERILCONTAINER SYSTEMKCT2012-05-04
1962121791241151K103400FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIPOLO2011-03-07
1962121063314303K101616THE GRAPPLR AND GRAPPLR EXTENDERMBI2011-01-06
1962122010750988K093677STRYKER ARTHROSCOPEHRX2010-03-05
1962121461653930K093206ORTHOMAP 3D 1.1 MODULEOLO2010-08-04
1962121354992126K082451STRYKER VIDEOSCOPEHET2008-12-16
1962121522523303K073017STRYKER STRI-SHIELD FLYTE TOGASFYA2007-11-30
1962121054371883K072180VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEMFAJ2007-12-18
1962121763050150K072127DOMINATORHWC2007-08-31
1962121953397192K071127FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEMHIH2007-11-16
1962121286111643K070882STRYKER PEEK TWINLOOP TACMBI2007-07-20
1962122016736586K070078STRYKER T4 HYTREL TOGAFYA2007-02-02
1962121735721389K06336745L CORE INSUFFLATOR, MODEL F114HIF2007-05-23
1962121875947578K063005STRYKER T6 HOODS AND TOGASFYA2007-03-23
1962121910433554K062380FLOSIMPLE ARTHROSCOPY PUMP A120HRX2006-12-14
1962121548779010K060808BRAINPRO, BRAINPRO ACCESSHAW2006-07-25
1962121703930464K060085STRYKER SCOPE/INSTRUMENT HOLDERGCJ2006-04-27
1962121529000652K042568EXCELSIOR 1018 AND SL-10 MICROCATHETERSDQY2004-10-15
1962121778750588K040390STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEMHIH2004-05-17
1962121102005894K030402ARTHROSCOPY PUMP, MODEL A107HRX2003-04-17
1962121257776001K023074IMBIBE BONE MARROW ASPIRATION SYRINGEFMF2003-03-11
1962121701855113K023013STRYKER XCEL ANCHOR SYSTEMHWC2003-02-26
1962121437535118K022579STRYKER NAVIGATION SYSTEM-KNEE MODULEHAW2003-06-02
1962121023519019K022449HYSTEREOSCOPY PUMP HM4HIG2003-04-10
1962121800304599K022365STRYKER NAVIGATION SYSTEM - HIP MODULEHAW2003-01-22
1962121037534223K021351BIOSTEON CROSS PINHWC2002-10-17
1962121459956669K020220ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTELFL2002-08-23
1962121119859070K013789EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189DQY2001-12-06
1962121478404986K012380MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPYHAW2001-12-03
1962121949611911K003792STRYKER HEATED INSUFFLATOR TUBE SETHIF2001-02-21
1962121950076289K003641BIOLOK SCREW, BIOSTEON SCREWHWC2001-02-08
1962121049146188K002732STRYKER NAVIGATION SYSTEM - ENT MODULEHAW2000-10-02
1962121342649522H050001
1962121047933528H020002
1962121762520993BK090048
1962121025812550
1962121150271391
1962121178091944
1962121303157043
1962121250390804

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
OLO172025-09-25
HAW102023-02-16
HRX92019-01-07
DQY82019-03-13
GEI62022-09-16
HCG52024-08-29
FYA52014-08-26
PGW42022-07-12
HIF42020-07-29
MBI42012-03-02
HWC42007-08-31
GCJ32006-04-27
NRY22019-03-13
QPB22017-03-24
HET22008-12-16
HIH22007-11-16
KWS12026-07-22
QJP12025-03-21
QIH12023-09-29
NDN12022-12-20
GWG12021-08-06
EOB12019-09-06
QCA12019-05-16
MOF12019-05-01
NAY12018-09-21
OUT12018-07-13
GZT12017-09-07
GXD12017-05-25
FCS12015-08-20
FXY12014-06-26
BTA12013-10-11
MJN12013-01-11
KCT12012-05-04
FAJ12007-12-18
HIG12003-04-10
FMF12003-03-11
LFL12002-08-23
KRA12000-08-03
OCZ11997-09-10
FSM11994-11-22