Company · US
Stryker Corporation
FDA 510(k) clearances and medical device recalls filed under this name, 1976 to 2026. Name variants (Inc, Corp, punctuation) are merged.
352510(k) clearances (3 in 12 months)
192recalls (18 in 12 months)
168recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | 49 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 44 |
| HRX | Arthroscope | 27 |
| HRS | Plate, Fixation, Bone | 26 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 26 |
| GCJ | Laparoscope, General & Plastic Surgery | 24 |
| HBE | Drills, Burrs, Trephines & Accessories (Simple, Powered) | 21 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 17 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 16 |
| NHB | Polymer, Ear, Nose And Throat, Synthetic, Absorbable | 14 |
| JEY | Plate, Bone | 13 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 10 |
| NKB | Thoracolumbosacral Pedicle Screw System | 10 |
| OLO | Orthopedic Stereotaxic Instrument | 9 |
| ERL | Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece | 8 |
| HAW | Neurological Stereotaxic Instrument | 8 |
| HWC | Screw, Fixation, Bone | 7 |
| KCY | Tourniquet, Pneumatic | 7 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 7 |
| LZN | Cement Obturator | 7 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 29, 2026 | K261481 | Pangea Femur Reconstruction System Stryker GmbH, CH | HSB |
| Feb 3, 2026 | K253640 | T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction System Stryker GmbH, CH | HSB |
| Dec 19, 2025 | K253202 | Hoffmann LRF System Stryker GmbH, CH | KTT |
| Aug 20, 2025 | K251400 | T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing System Stryker GmbH, CH | HSB |
| Aug 13, 2025 | K250163 | T2 Alpha Femur Retrograde Nailing System Stryker GmbH, CH | HSB |
| Oct 6, 2024 | K242445 | Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System Stryker GmbH, CH | HRS |
| Mar 25, 2024 | K233919 | VariAx 2 Distal Radius System Stryker GmbH, CH | HRS |
| Dec 21, 2023 | K233741 | Hoffmann LRF System Stryker GmbH, CH | KTT |
| Sep 29, 2023 | K230045 | HipCheck Stryker Corp. | QIH |
| Sep 20, 2023 | K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM Stryker | OWN |
| Aug 18, 2023 | K232157 | Connected OR Hub with Device and Voice Control, SDC4K Information Management System with Device and Voice Control Stryker Corporation | GCJ |
| Aug 18, 2023 | K231262 | Pangea Femur Plating System, Pangea Fibula Plating System, Pangea Tibia Plating System, Pangea Humerus Plating System Stryker GmbH | HRS |
| Aug 18, 2023 | K231257 | Pangea Utility Plating System, Pangea Platform Stryker GmbH | HRS |
| Jun 9, 2023 | K230512 | Gamma4 System Stryker GmbH | HSB |
| May 19, 2023 | K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® Stryker | KRO |
| Apr 27, 2023 | K222381 | PeriPRO Femur System, Variable Angle Fixation System, AxSOS 3Ti, Stryker Plating System Stryker GmbH | HRS |
| Apr 11, 2023 | K230754 | L12 LED Light Source with AIM Stryker | OWN |
| Apr 7, 2023 | K223772 | PRO Plating System, Stryker Trauma Pelvic Set (Matta) Stryker GmbH | HRS |
| Mar 31, 2023 | K230605 | 1788 4K Camera System with Advanced Imaging Modality Stryker | GCJ |
| Feb 23, 2023 | K230216 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) Stryker | GCJ |
| Feb 16, 2023 | K223770 | Sonopet 1Q 3 7cm 1Q Large Stryker Corporation | LFL |
| Feb 16, 2023 | K212194 | Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker and Microscope Tracker, Passive Optical Na Stryker Corporation, DE | HAW |
| Nov 15, 2022 | K222309 | Gamma4 System Stryker GmbH | HSB |
| Oct 19, 2022 | K221728 | Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System, DynaTran Anterior Cervical Plating (ACP) System, R Stryker Corporation | KWQ |
| Sep 16, 2022 | K221074 | OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion Device Stryker Corporation | GEI |
| Aug 19, 2022 | K222130 | 1688 4K Camera System with Advanced Imaging Modality Stryker | GCJ |
| Aug 11, 2022 | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem Stryker | MEH |
| Jul 12, 2022 | K221098 | Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software, Electromagnetic Navigation Unit Stryker Corporation, DE | PGW |
| Jul 8, 2022 | K221346 | Stryker VariAx 2 MIS Calcaneus Stryker GmbH | HRS |
| Jun 29, 2022 | K221611 | 780 nm L11 LED Light Source with AIM Stryker | OWN |
| Jun 17, 2022 | K221217 | SPY Laparoscope Stryker | GCJ |
| Jun 10, 2022 | K220319 | Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw System Stryker GmbH | HWC |
| Jun 10, 2022 | K210582 | EasyClip® and EasyClip® Xpress Stryker GmbH | JDR |
| May 25, 2022 | K214046 | 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable Stryker | GCJ |
| Apr 22, 2022 | K220895 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) Stryker | GCJ |
| Feb 11, 2022 | K213328 | Gamma4 System, Gamma3 System, IMN Screws System, T2 Tibial Nailing System Stryker GmbH | HSB |
| Feb 3, 2022 | K213824 | Sonopet iQ Ultrasonic Aspirator System Stryker Corporation | LFL |
| Jan 19, 2022 | K212581 | VariAx 2 Distal Radius System, VariAx 2 Distal Ulna System Stryker GmbH | HRS |
| Jan 11, 2022 | K213199 | Asnis® III Cannulated Screw System and Asnis® PRO Cannulated Screw System Stryker GmbH | HWC |
| Dec 16, 2021 | K212055 | Connected OR Hub with Device and Voice Control Stryker Corporation | GCJ |
| Nov 4, 2021 | K212511 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (16884101 Stryker | GCJ |
| Oct 5, 2021 | K211508 | Steinmann Pins and Kirschner Wires Stryker GmbH | JDW |
| Sep 3, 2021 | K210861 | ReUnion Reversible Fracture System (RFX), ReUnion Reverse Shoulder Arthroplasty System (RSA), ReUnion Total Shoulder Art Stryker GmbH | KWS |
| Aug 6, 2021 | K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes Stryker | GWG |
| Jun 30, 2021 | K210377 | Stryker iBur hubs and cutting accessories Stryker Corporation | HBE |
| Jun 18, 2021 | K202964 | iBed Wireless with iBed Mobile Stryker Corporation | FNL |
| Jun 9, 2021 | K211490 | Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Number 5407-350-000 Stryker Corporation | ERL |
| Apr 13, 2021 | K210088 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes Stryker | GCJ |
| Mar 18, 2021 | K210584 | SDC3 HD Information Management System with Wireless Device Control Capability Stryker | GCJ |
| Feb 26, 2021 | K203819 | T2 Alpha Femur Retrograde Nailing System, T2 Alpha Femur Antegrade GT/PF Nailing System, T2 Tibial Nailing System, T2 Fe Stryker GmbH | HSB |
Newest 50 of 352.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 3, 2026 | Stryker Corporation STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540 Open, Classified |
GEI | K963646 |
| Aug 3, 2026 | Stryker Corporation STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530 Open, Classified |
GEI | K963646 |
| Aug 3, 2026 | Stryker Corporation STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640 Open, Classified |
GCX | K042454 |
| Aug 3, 2026 | Stryker Corporation STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620 Open, Classified |
GCX | K042454 |
| Aug 3, 2026 | Stryker Corporation STRYKER AHTO TUBE SET PACKAGING, Catalog Number 0250070600 Open, Classified |
GCX | K042454 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 150mm. Catalog Number: 50796150. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 120mm. Catalog Number: 50796120. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 90mm. Catalog Number: 50796090. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 60mm. Catalog Number: 50796060. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 50mm. Catalog Number: 50796050. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 40mm. Catalog Number: 50796040. Open, Classified |
KTT | K033476 |
| Jul 29, 2026 | Stryker GmbH Stryker Hoffmann II Connecting Rod Micro 3 x 30mm. Catalog Number: 50796030. Open, Classified |
KTT | K033476 |
| Jun 1, 2026 | Stryker Corporation Neptune Smart Docking Station (120V), Catalog Number 0770-100-000, part of the Neptune Waste Management System Open, Classified |
JCX | K132671 |
| May 12, 2026 | Stryker Corporation 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 irrigat Open, Classified |
HIG | K172048 |
| Feb 17, 2026 | Stryker Corporation 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 Open, Classified |
NEU | K231579 K253888 |
| Nov 26, 2025 | Stryker Corporation 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 She Open, Classified |
GEI | K191599 |
| Nov 26, 2025 | Stryker Corporation NICO Myriad Illumination Pack
Product No. NN-1000
11g Illumination Sleeve/Fiber;
Product No. NN-1001
13g Illumination Sleeve/Fiber Open, Classified |
GEI | K191599 K232567 |
| Nov 26, 2025 | Stryker Corporation 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 Open, Classified |
GEI | K191599 |
| Aug 7, 2025 | Stryker Corporation 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 Open, Classified |
KCY | None listed |
| Jul 23, 2025 | Stryker Corporation Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip Open, Classified |
GCX | K954726 |
| Jul 23, 2025 | Stryker Corporation Stryker, StrykeFlow , REF: 0250070500, 2, Disposable Suction/Irrigator without Disposable Tip Open, Classified |
GCJ | K934094 |
| Jun 10, 2025 | Stryker GmbH Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S. Open, Classified |
HSB | K101438 |
| Jun 10, 2025 | Stryker GmbH Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S. Open, Classified |
HSB | K101438 |
| Jun 6, 2025 | Stryker GmbH Long Nail, RIGHT Gamma4 10x320mm x 125, component of the Gamma4 System. Catalog Number: 84250320S. Open, Classified |
HSB | K213328 |
| Apr 17, 2025 | Stryker GmbH Guide Wire with Ruler Tube 3x1000 mm DIA; Catalog number/REF: 2351-3100S; Open, Classified |
LXH | None listed |
| Apr 17, 2025 | Stryker GmbH Guide Wire with Ruler Tube 3x800 mm DIA; Catalog number/REF: 2351-3080S; Open, Classified |
LXH | None listed |
| Mar 28, 2025 | Stryker Corporation Hemopore 2PK nasal/sinus temporary wound dressing, Catalog Number 5400-222-208S Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Nasopore 4cm Standard 2PK fragmentable nasal dressing, Catalog Number 5400-212-004S and Nasopore 4cm Firm 2PK Catalog Number 5400-222-004S Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Nasopore Ex Firm 8cm fragmentable nasal dressing, Catalog Number 5400-030-008 and Nasopore Forte plus 8cm Catalog Number 5400-030-008ITL Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Nasopore Ex Firm 4cm fragmentable nasal dressing, Catalog Number 5400-030-004 and Nasopore Forte plus 4cm Catalog Number 5400-030-004ITL Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Hemopore 8cm nasal/sinus temporary wound dressing, Catalog Numbers 5400-020-208 and 5400-020-208ITL (OUS) Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Nasopore FD fragmentable nasal dressing, Catalog Numbers 5400-020-108 and 5400-020-108ITL Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Otopore Square outer ear wound dressing, Firm Catalog Number 5400-020-100 and Forte Catalog Number 5400-020-100ITL Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Nasopore 4cm fragmentable nasal dressing, Firm Catalog Number 5400-020-004 and Forte Catalog Number 5400-020-004ITL Open, Classified |
NHB | None listed |
| Mar 28, 2025 | Stryker Corporation Nasopore 8cm fragmentable nasal dressing, Firm Catalog Number 5400-020-008 and Forte Catalog Number 5400-020-008ITL Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Otopore Cylinder outer ear wound dressing, Firm Catalog Number 5400-020-000 and Forte Catalog Number 5400-020-000TL Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Nasopore Standard 8cm fragmentable nasal dressing, Catalog Numbers 5400-010-008 and 5400-010-008ITL Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Nasopore Standard 4cm fragmentable nasal dressing, Catalog Numbers 5400-010-004 and 5400-010-004ITL Open, Classified |
NHB | K070715 |
| Mar 28, 2025 | Stryker Corporation Otopore Cylinder Standard outer ear dressings, Catalog Numbers 5400-010-000 and 5400-010-000ITL Open, Classified |
NHB | K070715 |
| Mar 12, 2025 | Stryker Corporation Stryker CinchLock Flex Knotless Anchor with Inserter and Suture, REF CAT02643, Sterile EO, Rx Only MR Safe CE 0197 Open, Classified |
MBI | K151314 |
| Feb 11, 2025 | Stryker Corporation stryker Precision Thin, Catalog Number REF 2296-003-155; Micro Oscillating and Sagittal Blades Open, Classified |
GEI | None listed |
| Feb 11, 2025 | Stryker Corporation stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating and Sagittal Blades Open, Classified |
GEI | K143145 |
| Jan 17, 2025 | Stryker Corporation stryker 3.0MM Precision Neuro Match Head, REF 5820-107-530, used to cut bone and bone cement during neurosurgery Open, Classified |
HBE | K143320 |
| Jan 17, 2025 | Stryker Corporation stryker 3.0MM Neuro Match Head, REF 5820-107-430, used to cut bone and bone cement during neurosurgery Open, Classified |
HBE | K143320 |
| Jan 17, 2025 | Stryker Corporation The 3.0MM Neuro Match Head Soft Touch bur (5820-107-030) is intended to be used to cut bone and bone cement during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat Open, Classified |
HBE | K143320 |
| Jan 6, 2025 | Stryker Corporation 100V NEPTUNE 3 ROVER JAPANESE (0703-003-000)
120V NEPTUNE S ROVER (0711-001-000)
230V NEPTUNE 3 ROVER ENGLISH (0703-002-000ENG)
230V NEPTUNE 3 ROVER SPANISH (0703-002-000ES) Open, Classified |
GEI | K143145 |
| Nov 13, 2024 | Stryker Corporation Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke genera Open, Classified |
GEI | K143145 |
| Nov 13, 2024 | Stryker Corporation Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generate Open, Classified |
GEI | K143145 |
| Nov 13, 2024 | Stryker Corporation Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke gen Open, Classified |
GEI | K143145 |
Newest 50 of 192.