Stryker Instruments
FDA 510(k) & PMA Approved Devices — 20 products
Total Devices20
Categories13
Latest FDA decision2026-06-17
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261544 | Hydro Irrigation System | EOB | 2026-06-17 | View |
| 510(k) | K253679 | Hydro Irrigation System | GWG | 2026-05-08 | View |
| 510(k) | K252282 | SurgiCount+ System | PBZ | 2026-03-16 | View |
| 510(k) | 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 | 2025-09-25 | View |
| 510(k) | K250483 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | GEI | 2025-09-09 | View |
| 510(k) | K250213 | OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit) | GXI | 2025-05-15 | View |
| 510(k) | K250327 | OptaBlate Radiofrequency (RF) Generator System | GEI | 2025-04-15 | View |
| 510(k) | K243930 | Sonopet iQ Ultrasonic Aspirator System (5500-050-000) | LFL | 2025-03-24 | View |
| 510(k) | K243958 | Consolidated Operating Room Equipment (CORE) 2 Console | OLO | 2025-03-21 | View |
| 510(k) | 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 | 2025-03-11 | View |
| 510(k) | K242834 | System 9 Sterile Battery Container | KCT | 2025-01-16 | View |
| 510(k) | K242266 | PhotonBlade 3; PhotonBlade 3 Smoke Evacuation | GEI | 2024-10-21 | View |
| 510(k) | K241272 | Stryker Steri-Shield 8 Surgical Hoods and Togas | FYA | 2024-10-16 | View |
| 510(k) | K240526 | POWEReam Xia/Serrato | NKB | 2024-04-29 | View |
| 510(k) | K232250 | SurgiCount+ System | PBZ | 2024-01-11 | View |
| 510(k) | K233300 | POWEReam 1/4 Drive | NKB | 2023-12-26 | View |
| 510(k) | K223294 | SpineJack® Expansion Kit | NDN | 2022-12-20 | View |
| 510(k) | K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen Collection Manifold Kit (0750-200-000);V2 Specimen Collection Tray (0750-210-000) | JCX | 2022-12-09 | View |
| 510(k) | K211238 | SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement | NDN | 2021-06-25 | View |
| 510(k) | K172367 | Stryker Integrated Bipolar Cord and Tubing Sets | GEI | 2017-08-22 | View |
No matching devices.