Stryker Corp.
Kalamazoo, MI, US
STRYKER CORP. appears in FDA device records in Kalamazoo, MI. FDA records list 568 510(k) clearances between and , 76 PMA records and 9 registered establishments. As of , FDA records show 1,076 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
6 namesFDA records resolved to Stryker Corp. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Stryker Endoscopyregistration, 510(k), enforcement report, recall
- Stryker Instrumentsregistration, 510(k), enforcement report, recall
- Stryker Instruments Div. of Stryker Corporationenforcement report, recall
- Stryker Instruments Division of Stryker Corporationrecall
- Stryker Instruments, Instruments Div.510(k), recall
- Stryker Neurovascularregistration, 510(k), PMA, enforcement report, recall
510(k) clearance history
Showing 50 of 568FDA records hold 568 510(k) clearances for Stryker Corp. between 1976 and 2026. The busiest year on record is 2015, with 32. The most recent is 2026, with 14.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 2 |
| 1977 | 4 |
| 1979 | 1 |
| 1981 | 1 |
| 1983 | 3 |
| 1984 | 4 |
| 1985 | 3 |
| 1986 | 3 |
| 1987 | 3 |
| 1988 | 3 |
| 1989 | 1 |
| 1991 | 3 |
| 1992 | 6 |
| 1993 | 3 |
| 1994 | 19 |
| 1995 | 16 |
| 1996 | 11 |
| 1997 | 11 |
| 1998 | 5 |
| 1999 | 12 |
| 2000 | 7 |
| 2001 | 14 |
| 2002 | 7 |
| 2003 | 18 |
| 2004 | 16 |
| 2005 | 9 |
| 2006 | 10 |
| 2007 | 13 |
| 2008 | 8 |
| 2009 | 7 |
| 2010 | 6 |
| 2011 | 15 |
| 2012 | 22 |
| 2013 | 15 |
| 2014 | 22 |
| 2015 | 32 |
| 2016 | 24 |
| 2017 | 27 |
| 2018 | 19 |
| 2019 | 30 |
| 2020 | 23 |
| 2021 | 20 |
| 2022 | 22 |
| 2023 | 20 |
| 2024 | 14 |
| 2025 | 20 |
| 2026 | 14 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K262369 | AIR+ All-Inside Meniscal Repair Device, Curved Up;AIR+ All-Inside Meniscal Repair Device, Curved Down | MBI | Substantially Equivalent | |
| DEN250040 | SportSuite Vision Software | SIT | Unknown | |
| K261889 | Trevo Trak 21 Microcatheter | QJP | Substantially Equivalent | |
| K261481 | Pangea Femur Reconstruction System | HSB | Substantially Equivalent | |
| K261544 | Hydro Irrigation System | EOB | Substantially Equivalent | |
| K253602 | Precision S 4K Sinuscope | GWG | Substantially Equivalent | |
| K261037 | 780 nm SPY Portable Handheld Imaging (SPY-PHI) System | IZI | Substantially Equivalent | |
| K253679 | Hydro Irrigation System | GWG | Substantially Equivalent | |
| K252282 | SurgiCount+ System | PBZ | Substantially Equivalent | |
| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality | GCJ | Substantially Equivalent | |
| K260108 | L12 LED Light Source with AIM | OWN | Substantially Equivalent | |
| K253032 | AXS Lift Intracranial Base Catheter | QJP | Substantially Equivalent | |
| K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System | HSB | Substantially Equivalent | |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | GCJ | Substantially Equivalent | |
| K253888 | MOLLI 2 System | NEU | Substantially Equivalent | |
| K253202 | Hoffmann LRF System | KTT | Substantially Equivalent | |
| K252694 | Target Detachable Coil | HCG | Substantially Equivalent | |
| K251832 | InZone IST Detachment System; IZDS Connecting Cable | HCG | Substantially Equivalent | |
| 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 | |
| K250483 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | GEI | Substantially Equivalent | |
| K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System | HSB | Substantially Equivalent | |
| K250163 | T2 Alpha Femur Retrograde Nailing System | HSB | Substantially Equivalent | |
| K252010 | SPY Laparoscope | GCJ | Substantially Equivalent | |
| K252012 | SPY Cystoscope/Hysteroscope | HIH | Substantially Equivalent | |
| K250544 | Knotilus+ Biocomposite Knotless Anchor | MAI | Substantially Equivalent | |
| K250528 | Stryker AlphaVent™ Knotless SP Biocomposite Anchor | MAI | Substantially Equivalent | |
| K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) | GXI | Substantially Equivalent | |
| K250327 | OptaBlate Radiofrequency (RF) Generator System | GEI | Substantially Equivalent | |
| K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000) | LFL | Substantially Equivalent | |
| K243958 | Consolidated Operating Room Equipment (CORE) 2 Console | OLO | Substantially Equivalent | |
| 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 | |
| K250374 | iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R | HBE | Substantially Equivalent | |
| K243593 | AXS Lift Intracranial Base Catheter | QJP | Substantially Equivalent | |
| K242834 | System 9 Sterile Battery Container | KCT | Substantially Equivalent | |
| K241768 | Broadway 8 Catheter | QJP | Substantially Equivalent | |
| K241637 | Echo Intracranial Base Catheter | QJP | Substantially Equivalent | |
| K242266 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | GEI | Substantially Equivalent | |
| K241272 | Stryker Steri-Shield 8 Surgical Hoods and Togas | FYA | Substantially Equivalent | |
| K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System | HRS | Substantially Equivalent | |
| K241401 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with Device and Voice Control | GCJ | Substantially Equivalent | |
| K240526 | POWEReam Xia/Serrato | NKB | Substantially Equivalent | |
| K233919 | VariAx 2 Distal Radius System | HRS | Substantially Equivalent | |
| K240407 | ICONIX All-Suture Anchor; ICONIX TT All-Suture Anchor; ICONIX with Needles All-Suture Anchor | MBI | Substantially Equivalent | |
| K240174 | 1688 4K Camera System with Advanced Imaging Modality | GCJ | Substantially Equivalent | |
| K233635 | SPY Cystoscope/Hysteroscope | HIH | Substantially Equivalent | |
| K233893 | AlphaVent Knotless SP PEEK Anchor | MBI | Substantially Equivalent | |
| K232250 | SurgiCount+ System | PBZ | Substantially Equivalent | |
| K233327 | 1788 4K Camera System with Advanced Imaging Modality | GCJ | Substantially Equivalent | |
| K233300 | POWEReam 1/4 Drive | NKB | Substantially Equivalent | |
| K233741 | Hoffmann LRF System | KTT | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1811755 | 1811755 | STRYKER CORP. | 4100 EAST MILHAM AVE., KALAMAZOO, MI 49001 US | 2026 | |
| 2936485 | 2936485 | STRYKER ENDOSCOPY | 5900 Optical Ct, SAN JOSE, CA 95138 US | 2026 | and 100 more, listed in full below |
| 8031020 | 3002807830 | STRYKER GmbH | BOHNACKERWEG 1, SELZACH Solothurn 2545 CH | 2026 | and 51 more, listed in full below |
| 3012103978 | 3012103978 | Stryker Endoscopy | 5670 Greenwood Plaza Blvd, Greenwood Village, CO 80111 US | 2026 | |
| 3015439135 | 3015439135 | Stryker Endoscopy | 50 Wellington Street East, Toronto Ontario M5E 1C8 CA | 2026 | |
| 3015967359 | 3015967359 | Stryker Instruments | 1941 Stryker Way, Portage, MI 49002 US | 2026 | and 91 more, listed in full below |
| 3008853977 | 3008853977 | Stryker Neurovascular | 47900 Bayside Parkway, Fremont, CA 94538 US | 2026 | and 7 more, listed in full below |
| 3008881809 | 3008881809 | Stryker Neurovascular | Business and Technology Park, Cork Munster 00000 IE | 2026 | |
| 3012931345 | 3012931345 | Stryker Neurovascular | 4870 West 2100 South, Salt Lake City, UT 84120 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FEMAccessories, Photographic, For Endoscope (Exclude Light Sources)
- FFYAdaptor, Bulbs, Miscellaneous, For Endoscope
- DTLAdaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CACApparatus, Autotransfusion
- EMXBalloon, Epistaxis
- FNLBed, Ac-Powered Adjustable Hospital
- FMSBed, Pediatric Open Hospital
- DWHBlade, Saw, Surgical, Cardiovascular
- FATBougie, Esophageal, And Gastrointestinal, Gastro-Urology
- EJLBur, Dental
- EQJBur, Ear, Nose And Throat
- BZNCart, Emergency, Cardiopulmonary (Excluding Equipment)
- BSOCatheter, Conduction, Anesthetic
- DQOCatheter, Intravascular, Diagnostic
- DQYCatheter, Percutaneous
- FMHContainer, Specimen, Sterile
- FAJCystoscope And Accessories, Flexible/Rigid
- FGODislodger, Stone, Flexible
- DZIDrill, Bone, Powered
- ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- DZJDriver, Wire, And Bone Drill, Manual
- FASElectrode, Electrosurgical, Active, Urological
- FEDEndoscopic Access Overtube, Gastroenterology-Urology
- FETEndoscopic Video Imaging System/Component, Gastroenterology-Urology
- BXBExerciser, Powered
- FFSImage, Illumination, Fiberoptic, For Endoscope
- DZEImplant, Endosseous, Root-Form
- DYBIntroducer, Catheter
- FQHLavage, Jet
- FCWLight Source, Fiberoptic, Routine
- FCSLight, Catheter, Fiberoptic, Glass, Ureteral
- EAYLight, Fiber Optic, Dental
- EBALight, Surgical Headlight
- EPTMicroscope, Surgical
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- FLNMonitor, Electric For Gravity Flow Infusion Systems
- EOBNasopharyngoscope (Flexible Or Rigid)
- BSPNeedle, Conduction, Anesthetic (W/Wo Introducer)
- FRNPump, Infusion
- BTAPump, Portable, Aspiration (Manual Or Powered)
- ETAReplacement, Ossicular Prosthesis, Total
- FDCResectoscope, Working Element
- DZLScrew, Fixation, Intraosseous
- EQHSource, Carrier, Fiberoptic Light
- FOXStand, Infusion
- FLESterilizer, Steam
- ETNStimulator, Nerve
- FPPStretcher, Hand-Carried
- FPOStretcher, Wheeled
- FMFSyringe, Piston
- FQOTable, Operating-Room, Ac-Powered
- BYZTrap, Sterile Specimen
- FSMTray, Surgical, Instrument
- BYYTube, Aspirating, Flexible, Connecting
- FCZTube, Smoke Removal, Endoscopic
- BYXTubing, Pressure And Accessories
- EIAUnit, Operative Dental
- FGBUreteroscope And Accessories, Flexible/Rigid
- DQXWire, Guide, Catheter
Recall records
Showing 25 of 1,076| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2833-2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Open, Classified | |
| Z-2832-2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Open, Classified | |
| Z-2831-2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Open, Classified | |
| Z-2830-2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Open, Classified | |
| Z-2829-2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Open, Classified | |
| Z-2828-2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Open, Classified | |
| Z-2827-2026 | Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030. | Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. | Class II | Open, Classified | |
| Z-2866-2026 | STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540 | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. | Class II | Open, Classified | |
| Z-2865-2026 | STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530 | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. | Class II | Open, Classified | |
| Z-2864-2026 | STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640 | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. | Class II | Open, Classified | |
| Z-2863-2026 | STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620 | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. | Class II | Open, Classified | |
| Z-2862-2026 | STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600 | There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use. | Class II | Open, Classified | |
| Z-2282-2026 | Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System | It has been identified that the impacted docking station (SN 2521008873) was not product released from manufacturing and may not have completed required testing prior to being shipped to your facility. There is a potential risk of electrical shock due to the device s safety testing being unverifiable. | Class II | Open, Classified | |
| Z-2166-2026 | Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warming, and volume/deficit measurements in endoscopic procedures within gynecology, urology, and orthopedic disciplines. | Due to nonconforming products being inadvertently distributed. | Class II | Open, Classified | |
| Z-2552-2026 | INZONE DETACHMENT SYSTEM, REF: M00345100950 | Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique. | Class II | Open, Classified | |
| Z-1427-2026 | MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195134 MP2001 - MOLLI 2 Wand UDI (GTIN): 00850024195141 MP2015A - MOLLI OncoPen UDI (GTIN): 00850024195219 MT2001 - MOLLI 2 Tablet UDI (GTIN): 00850024195158 The MOLLI Marker is intended to be placed percutaneously in soft tissue to temporarily mark a surgical site intended for surgical removal. the MOLLI Marker is located and surgically removed with the target tissue. | Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during target tissue removal procedures. | Class II | Open, Classified | |
| Z-0601-2026 | NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BrainPath Shephard's Hook - Greenberg LK; | Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction. | Class II | Open, Classified | |
| Z-0600-2026 | NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber | Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction. | Class II | Open, Classified | |
| Z-0599-2026 | NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAAB; NN-8006 11X10 MHP; NN-8007 11x13 MHP; NN-8008 19x28 MHP OI; NN-8010 17x31.5 MHP DECQ; NN-8015 NICO Fluid System (NFS); NN-8017 11x13 MHP/PB; NN-8018 13X13 MHP/PB; NN-8019 19x28 MHP Little LOTTA; NN-8020 19x21.5 MHP PaediScope; NN-8021 15x26.5 MHP LOTTA; NN-8500 15x10 MHP; NN-8501 15x13 MHP; NN-8502 15x25 MINOP MHP; NN-8503 13x10 MHP; NN-8504 13x13 MHP; NN-8505 15x25 GAAB MHP; NN-8506 11X10 MHP; NN-8507 11x13 MHP; NN-8508 19x28 OI MHP; NN-8510 17x31.5 DECQ MHP; NN-8517 13X13 MHP/PB; NN-8518 11x13 MHP/PB; NN-8519 19x28 Little LOTTA MHP; NN-8520 19x21.5 PaediScope MHP; NN-8521 15X26.5 LOTTA MHP; | Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction. | Class II | Open, Classified | |
| Z-2277-2025 | Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235 | Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics. | Class II | Open, Classified | |
| Z-2171-2025 | Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip | Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction. | Class II | Open, Classified | |
| Z-2170-2025 | Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip | Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction. | Class II | Open, Classified | |
| Z-1914-2025 | Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S. | Investigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail. | Class II | Open, Classified | |
| Z-1940-2025 | Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S. | Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail. | Class II | Open, Classified | |
| Z-1939-2025 | Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S. | Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left version but contained a right nail and another lot was labeled as right version but contained a left nail. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain