Stryker
FDA 510(k) & PMA Approved Devices — 64 products
Total Devices64
Categories24
Latest FDA decision2023-09-20
SEC Filings: 2 filings on record. Latest: 10-Q (2026-07-31). View on SEC EDGAR →
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K231854 | 1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM | OWN | 2023-09-20 | View |
| 510(k) | K230416 | Triathlon® Hinge Knee System; Triathlon® Revision Insert X3® | KRO | 2023-05-19 | View |
| 510(k) | K230754 | L12 LED Light Source with AIM | OWN | 2023-04-11 | View |
| 510(k) | K230605 | 1788 4K Camera System with Advanced Imaging Modality | GCJ | 2023-03-31 | View |
| 510(k) | K230216 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000) | GCJ | 2023-02-23 | View |
| 510(k) | K222130 | 1688 4K Camera System with Advanced Imaging Modality | GCJ | 2022-08-19 | View |
| 510(k) | K220731 | Insignia Hip Stem, Restoration Modular 115mm Conical Distal Stem | MEH | 2022-08-11 | View |
| 510(k) | K221611 | 780 nm L11 LED Light Source with AIM | OWN | 2022-06-29 | View |
| 510(k) | K221217 | SPY Laparoscope | GCJ | 2022-06-17 | View |
| 510(k) | K214046 | 780 nm 1688 4K Camera System, 780 nm L11 LED Light Source with AIM and Safelight Cable | GCJ | 2022-05-25 | View |
| 510(k) | K220895 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), 1688 4K Pendulum Camera Head (1688310130) | GCJ | 2022-04-22 | View |
| 510(k) | K212511 | 1688 4K Camera Control Unit with Advanced Imaging Modality (1688010000), AIM 4K Autoclave Camera Head, C-Mount (1688410105), AIM 4K Autoclave Coupler, C-Mount (1688410110) | GCJ | 2021-11-04 | View |
| 510(k) | K211202 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, Precision S 4K Sinuscopes | GWG | 2021-08-06 | View |
| 510(k) | K210088 | 1688 4K Camera System, L11 LED Light Source with AIM, AIM SafeLight Cable, AIM Laparoscopes | GCJ | 2021-04-13 | View |
| 510(k) | K210584 | SDC3 HD Information Management System with Wireless Device Control Capability | GCJ | 2021-03-18 | View |
| 510(k) | K203055 | Stryker PEEK Customized Cranial Implant Kit | GWO | 2021-02-09 | View |
| 510(k) | K202659 | Stryker Arthroscope | HRX | 2020-12-01 | View |
| 510(k) | K202355 | Stryker Omega PEEK Knotless Anchor System | MBI | 2020-11-13 | View |
| 510(k) | K202592 | Adavanced Imaging Modality System (1688 4K Camera System With Advanced Imaging Modality, L11 LED Light Source with Adavanced Imaging Modality) | GCJ | 2020-10-08 | View |
| 510(k) | K201434 | Connected OR Hub with Voice Control, Connected OR Hub with Device Control | GCJ | 2020-07-28 | View |
No matching devices.
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