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Stryker Instruments FDA Approvals
0 new drug approvals and 20 device clearances on file. Matched by name to SYK.
Newest first
A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.
| Product |
|---|
| Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)510(k)Sep 17, 2026General, Plastic Surgery |
| Hydro Irrigation System510(k)Jun 17, 2026Ear, Nose, Throat |
| Hydro Irrigation System510(k)May 8, 2026Neurology |
| SurgiCount+ System510(k)Mar 16, 2026General Hospital |
| RPS Primary TKA Software; RPS Console; RPS Saw One; RPS Cable; RPS Saw Oscillating Tip Cartridge; RPS Console Cart Attachment; Ball Tip Pointer510(k)Sep 25, 2025Neurology |
| PhotonBlade 3; PhotonBlade 3 Smoke Evacuation510(k)Sep 9, 2025General, Plastic Surgery |
| OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit); OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Dual Kit)510(k)May 15, 2025Neurology |
| OptaBlate Radiofrequency (RF) Generator System510(k)Apr 15, 2025General, Plastic Surgery |
| Sonopet iQ Ultrasonic Aspirator System (5500-050-000)510(k)Mar 24, 2025 |
| Consolidated Operating Room Equipment (CORE) 2 Console510(k)Mar 21, 2025Neurology |
| 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 R510(k)Mar 11, 2025Neurology |
| System 9 Sterile Battery Container510(k)Jan 16, 2025General Hospital |
| PhotonBlade 3; PhotonBlade 3 Smoke Evacuation510(k)Oct 21, 2024General, Plastic Surgery |
| Stryker Steri-Shield 8 Surgical Hoods and Togas510(k)Oct 16, 2024General, Plastic Surgery |
| POWEReam Xia/Serrato510(k)Apr 29, 2024Orthopedic |
| SurgiCount+ System510(k)Jan 11, 2024General Hospital |
| POWEReam 1/4 Drive510(k)Dec 26, 2023Orthopedic |
| SpineJack® Expansion Kit510(k)Dec 20, 2022Orthopedic |
| 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)510(k)Dec 9, 2022General, Plastic Surgery |
| SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement510(k)Jun 25, 2021Orthopedic |