Data / Medical devices / Netherlands / STRYKER EMEA Supply Chain Services
STRYKER EMEA Supply Chain Services: FDA-registered device maker in Venlo Limburg, Netherlands, 107 510(k) clearances and 2 PMA approvals
STRYKER EMEA Supply Chain Services is registered with the FDA (registration 3008837339) in Venlo Limburg, Netherlands. It lists 75 device types. The FDA files 107 510(k) clearances and 2 PMA approvals under its listings, the newest dated July 22, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3008837339
- Address
- Frans Maasweg 2, Venlo Limburg, Netherlands, 5928 SB
- Owner or operator
- STRYKER CORP. (1811755)
- Roles
- Exporter to the US
- First device listed
- June 9, 1986
- Registered through
- 2026
- Brand names listed
- 01030100 HipCheck, 01030300 HipCheck Software, 1.3MM X 35.6CM NITINOL GUIDE WIRE, 1.9MM 30° NON-AUTOCLAVABLE ARTHROSCOPE W/SPEEDLOCK, C-MOUNT, 1.9MM OBTURATOR, 1.9MM SPEEDLOCK PENCIL TIP OBTURATOR, 1.9MM TROCAR, 1.9MM X 30º C-MOUNT, A/C and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 107.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 22, 2026 | K260721 | Tornier Perform Advanced Glenoid | KWS | Substantially Equivalent | Tornier, Inc. | accessdata.fda.gov |
| September 25, 2025 | K251971 | RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer | OLO | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| March 21, 2025 | K242289 | Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior XT-27 Pre-Shaped Microcatheter, Excelsior XT-27 Flex Pre-Shaped Microcatheter | QJP | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| November 7, 2024 | K242373 | Mako Shoulder Application (1.0) | OLO | Substantially Equivalent | Mako Surgical Corp. | accessdata.fda.gov |
| August 29, 2024 | K242243 | Target Detachable Coils | HCG | Substantially Equivalent | Stryker Neurovscular | accessdata.fda.gov |
| August 27, 2024 | K241517 | Q Guidance System; Mako Spine System; | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| June 6, 2024 | K240662 | Spine 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 Handpiece | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| March 14, 2024 | K233542 | Ortho Guidance Precision Knee Software; Ortho Guidance Express Knee Software; Ortho Guidance Versatile Hip Software; Q Guidance System | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| September 29, 2023 | K230045 | HipCheck | QIH | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| February 16, 2023 | K212194 | Stryker 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 System | HAW | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| February 13, 2023 | K223767 | Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software, Ortho Guidance Versatile Hip Software, Ortho Q Guidance System | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| December 20, 2022 | K223294 | SpineJack® Expansion Kit | NDN | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| December 14, 2022 | K222533 | Target Tetra Detachable Coils | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| September 16, 2022 | K221074 | OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device | GEI | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| July 12, 2022 | K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit | PGW | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| May 27, 2022 | K220593 | Spine Guidance Software, Stryker Q Guidance System | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| August 6, 2021 | K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes | GWG | Substantially Equivalent | Stryker | accessdata.fda.gov |
| December 18, 2020 | K202749 | ADAPT for Gamma3 | OLO | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| October 9, 2020 | K202609 | Instrument Clamps Electromagnetic | PGW | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| July 29, 2020 | K201361 | PNEUMOCLEAR | HIF | Substantially Equivalent | W.O.M. World of Medicine GmbH | accessdata.fda.gov |
| September 6, 2019 | K191102 | Precision S 4K Sinuscope | EOB | Substantially Equivalent | Stryker | accessdata.fda.gov |
| May 1, 2019 | K190843 | Synchro2 Support Guidewire | MOF | Substantially Equivalent | Stryker | accessdata.fda.gov |
| March 13, 2019 | K183464 | AXS Catalyst 7 Distal Access Catheter (068 x 115cm, 068 x 125cm, 068 x 132cm) | NRY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| March 13, 2019 | K183463 | AXS Catalyst Distal Access Catheter 068 x 115cm, AXS Catalyst Distal Access Catheter 068 x 125cm, AXS Catalyst Distal Access Catheter 068 x 132cm | DQY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| February 14, 2019 | K183196 | Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy Trackers and Fluoroscopy Adapters, SpineMask Tracker | OLO | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| January 7, 2019 | K183470 | Precision Ideal Eyes Arthroscopes | HRX | Substantially Equivalent | Stryker | accessdata.fda.gov |
| December 14, 2018 | K182354 | SafeAir Telescopic Smoke Pencil | GEI | Substantially Equivalent | Lina Medical Aps | accessdata.fda.gov |
| October 12, 2018 | K181848 | ADAPT for Gamma3, Gamma3 | OLO | Substantially Equivalent | Stryker GmbH | accessdata.fda.gov |
| September 21, 2018 | K171947 | SOLOASSIST II | NAY | Substantially Equivalent | Aktormed GmbH | accessdata.fda.gov |
| March 18, 2018 | K173841 | AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm | NRY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| October 18, 2017 | K172034 | Stryker 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 Tap | OLO | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| September 27, 2017 | K171661 | Scopis Extended Instrument Set EM | PGW | Substantially Equivalent | Scopis GmbH | accessdata.fda.gov |
| September 7, 2017 | K172433 | NICO BrainPath | GZT | Substantially Equivalent | Nico Corporation | accessdata.fda.gov |
| July 28, 2017 | K163259 | AXS Offset Delivery Assist Catheter | DQY | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| May 25, 2017 | K170242 | MultiGen 2 RF Generator System | GXD | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| May 15, 2017 | K170784 | PNEUMOCLEAR | HIF | Substantially Equivalent | W.O.M. World of Medicine GmbH | accessdata.fda.gov |
| March 24, 2017 | K170329 | Basic, Dominant Flex | QPB | Substantially Equivalent | Modela AG | accessdata.fda.gov |
| February 23, 2017 | K162937 | Stryker OrthoMap Versatile Hip System | OLO | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| February 22, 2017 | K162929 | Stryker Navigation System with CranialMap software application, Stryker CranialMap Planning software application, Stryker CranialMask Tracker | HAW | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| February 9, 2017 | K161491 | Scopis Hybrid Navigation System EM | PGW | Substantially Equivalent | Scopis GmbH | accessdata.fda.gov |
| October 12, 2016 | K162341 | Stryker OrthoMap Precision Knee system | OLO | Substantially Equivalent | Stryker Leibinger GmbH & Co KG | accessdata.fda.gov |
| July 7, 2016 | K153240 | Styrker OrthoMap Express Knee System | OLO | Substantially Equivalent | Stryker Corporate | accessdata.fda.gov |
| June 22, 2016 | K161429 | Target Detachable Coils | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| May 19, 2016 | K153658 | Target Detachable Coils | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| April 13, 2016 | K160693 | Neptune E-SEP Smoke Evacuation Pencil | GEI | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| January 22, 2016 | K153679 | Stryker Neptune E-SEP Smoke Evacuation Pencil | GEI | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| January 8, 2016 | K152876 | LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM | DQY | Substantially Equivalent | Tni Manufacturing, Inc. | accessdata.fda.gov |
| November 13, 2015 | K151667 | AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm | DQY | Substantially Equivalent | Stryker | accessdata.fda.gov |
| August 20, 2015 | K151243 | STRYKER INFRARED ILLUMINATION SYSTEM (IRIS) [AIM Light Source and IRIS Ureteral Kit] | FCS | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
| April 21, 2015 | K150134 | Basic, Dominant Flex, KV-6 | QPB | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| November 14, 2014 | K142565 | Excelsior XT-17 Microcatheter, Excelsior XT-17 Flex Microcatheter, Excelsior XT-17 Pre-Shaped Microcatheter, Excelsior XT-17 Flex Pre-Shaped Microcatheter | DQY | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| October 31, 2014 | K141941 | SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D | OLO | Substantially Equivalent | Stryker Corporate | accessdata.fda.gov |
| August 26, 2014 | K141095 | STRYKER STERI-SHIELD FLYTE HYBRID TOGAS | FYA | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| June 26, 2014 | K140588 | FLYTE HYBRID HOOD, FLYTE HYBRID HOOD WITH PEELAWAY LENS | FXY | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| October 18, 2013 | K131214 | CRANIAL MAP NEURO | HAW | Substantially Equivalent | Stryker Corporate | accessdata.fda.gov |
| October 11, 2013 | K130123 | BASIC AND DOMINANT FLEX SUCTION PUMPS | BTA | Substantially Equivalent | Medela AG | accessdata.fda.gov |
| September 27, 2013 | K130874 | STRYKER NAV3I PLATFORM | HAW | Substantially Equivalent | Stryker Corporate | accessdata.fda.gov |
| January 11, 2013 | K122576 | TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT | MJN | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| January 9, 2013 | K123441 | STRYKER CROSSFLOW ARTHROSCOPY PUMP | HRX | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
| November 30, 2012 | K123377 | TARGET DETACHABLE COIL | HCG | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| May 4, 2012 | K112671 | STERILCONTAINER SYSTEM | KCT | Substantially Equivalent | Aesculap, Ltd. | accessdata.fda.gov |
| April 20, 2012 | K113778 | EXCELSIOR XT-27 MICROCATHETER | DQY | Substantially Equivalent | Stryker Neurovascular | accessdata.fda.gov |
| March 2, 2012 | K113297 | KNOTILUS ANCHOR SYSTEM | MBI | Substantially Equivalent | T.A.G. Medical Products Corporation, Ltd. | accessdata.fda.gov |
| March 7, 2011 | K103400 | FLUOROMAP SOFTWARE, 9 FLUORODISC (BELT), 12 FLUORO DISC (BELT), CLOSE TUBE CLIP | OLO | Substantially Equivalent | Stryker Corporation | accessdata.fda.gov |
| January 6, 2011 | K101616 | THE GRAPPLR AND GRAPPLR EXTENDER | MBI | Substantially Equivalent | Tag Medical Corp. | accessdata.fda.gov |
| August 4, 2010 | K093206 | ORTHOMAP 3D 1.1 MODULE | OLO | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| March 5, 2010 | K093677 | STRYKER ARTHROSCOPE | HRX | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
| December 16, 2008 | K082451 | STRYKER VIDEOSCOPE | HET | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
| December 18, 2007 | K072180 | VISION-SCIENCES CST-5000 VIDEO CYSTOSCOPE WITH ENDOSHEATH SYSTEM | FAJ | Substantially Equivalent | Vision-Sciences, Inc. | accessdata.fda.gov |
| November 30, 2007 | K073017 | STRYKER STRI-SHIELD FLYTE TOGAS | FYA | Substantially Equivalent | Stryker Instruments, Instruments Div. | accessdata.fda.gov |
| November 16, 2007 | K071127 | FLEXIBLE HYSTEROSCOPE WITH ENDOSHEATH SYSTEM | HIH | Substantially Equivalent | Vision-Sciences, Inc. | accessdata.fda.gov |
| August 31, 2007 | K072127 | DOMINATOR | HWC | Substantially Equivalent | Biocomposites, Ltd. | accessdata.fda.gov |
| July 20, 2007 | K070882 | STRYKER PEEK TWINLOOP TAC | MBI | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
| May 23, 2007 | K063367 | 45L CORE INSUFFLATOR, MODEL F114 | HIF | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| March 23, 2007 | K063005 | STRYKER T6 HOODS AND TOGAS | FYA | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| February 2, 2007 | K070078 | STRYKER T4 HYTREL TOGA | FYA | Substantially Equivalent | Stryker Instruments, Instruments Div. | accessdata.fda.gov |
| December 14, 2006 | K062380 | FLOSIMPLE ARTHROSCOPY PUMP A120 | HRX | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| July 25, 2006 | K060808 | BRAINPRO, BRAINPRO ACCESS | HAW | Substantially Equivalent | PAJUNK GmbH Medizintechnologie | accessdata.fda.gov |
| April 27, 2006 | K060085 | STRYKER SCOPE/INSTRUMENT HOLDER | GCJ | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
| October 15, 2004 | K042568 | EXCELSIOR 1018 AND SL-10 MICROCATHETERS | DQY | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| May 17, 2004 | K040390 | STRYKER UROLOGY AND GYNECOLOGY HARDWARE SYSTEM | HIH | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
| June 2, 2003 | K022579 | STRYKER NAVIGATION SYSTEM-KNEE MODULE | HAW | Substantially Equivalent | Stryker Leibinger | accessdata.fda.gov |
| April 17, 2003 | K030402 | ARTHROSCOPY PUMP, MODEL A107 | HRX | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| April 10, 2003 | K022449 | HYSTEREOSCOPY PUMP HM4 | HIG | Substantially Equivalent | W.O.M. World of Medicine AG | accessdata.fda.gov |
| March 11, 2003 | K023074 | IMBIBE BONE MARROW ASPIRATION SYRINGE | FMF | Substantially Equivalent | Orthovita, Inc. | accessdata.fda.gov |
| February 26, 2003 | K023013 | STRYKER XCEL ANCHOR SYSTEM | HWC | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
| January 22, 2003 | K022365 | STRYKER NAVIGATION SYSTEM - HIP MODULE | HAW | Substantially Equivalent | Stryker Instruments | accessdata.fda.gov |
| August 23, 2002 | K020220 | ULTRASONIC STRAIGHT/ULTRASONIC KNIFE/ULTRASONIC RING CURRETTE | LFL | Substantially Equivalent | Synergetics, Inc. | accessdata.fda.gov |
| December 6, 2001 | K013789 | EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 | DQY | Substantially Equivalent | Boston Scientific, Target | accessdata.fda.gov |
| December 3, 2001 | K012380 | MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY | HAW | Substantially Equivalent | Stryker Leibinger | accessdata.fda.gov |
| February 21, 2001 | K003792 | STRYKER HEATED INSUFFLATOR TUBE SET | HIF | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| February 8, 2001 | K003641 | BIOLOK SCREW, BIOSTEON SCREW | HWC | Substantially Equivalent | Biocomposites, Ltd. | accessdata.fda.gov |
| October 2, 2000 | K002732 | STRYKER NAVIGATION SYSTEM - ENT MODULE | HAW | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| August 3, 2000 | K994155 | EXCELSIOR 1018 MICROCATHETER | KRA | Substantially Equivalent | Boston Scientific, Target | accessdata.fda.gov |
| January 18, 2000 | K993239 | STRYKER NAVIGATION SYSTEM - NEURO MODULE, MODEL 6000-XXX-XXX | HAW | Substantially Equivalent | Stryker Corp. | accessdata.fda.gov |
| October 27, 1999 | K993045 | BARIATRIC LAPAROSCOPE, MODEL 367 | GCJ | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
| December 18, 1998 | K983557 | STRYKER WEDGE SUTURE ANCHOR | MBI | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
| October 2, 1998 | K982375 | STRYKER HIP ARTHOROSCOPY SET | HRX | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
| September 10, 1997 | K973259 | K&W 2-PIECE TAKE-APART INSTRUMENTS(VARIOUS) | OCZ | Substantially Equivalent | Medical Creative Technologies, Inc. | accessdata.fda.gov |
| January 22, 1997 | K963304 | STRYKER TEMPEST ORTHOPEDIC PUMP | HRX | Substantially Equivalent | Stryker Endoscopy | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 16, 2019 | P180031 | Neuroform Atlas® Stent System | QCA | 12 | October 24, 2026 | accessdata.fda.gov |
| July 13, 2018 | P170024 | Surpass Streamline Flow Diverter | OUT | 26 | August 28, 2026 | accessdata.fda.gov |
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Updated October 24, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.