Stryker Instruments is one of 25889 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Stryker Instruments - FDA 510(k) Cleared Devices
Recent clearances: SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000), Sonopet iQ Series III Console (5700-050-000), Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100)
77
Total
77
Cleared
0
Denied
Stryker Instruments has 77 FDA 510(k) cleared medical devices. Based in Kalamazoo, US.
Latest FDA clearance: Oct 2026. Active since 1994.
Browse the FDA 510(k) cleared devices submitted by Stryker Instruments Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Entela, Inc. as regulatory consultant.
FDA 510(k) Regulatory Record - Stryker Instruments
77 devices
Cleared
Oct 20, 2026
SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000)
General & Plastic Surgery
99d
Cleared
Oct 08, 2026
Sonopet iQ Series III Console (5700-050-000)
General & Plastic Surgery
99d
Cleared
Sep 17, 2026
Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade,...
General & Plastic Surgery
98d
Cleared
Jun 17, 2026
Hydro Irrigation System
Ear, Nose, Throat
40d
Cleared
May 08, 2026
Hydro Irrigation System
Neurology
168d
Cleared
Mar 16, 2026
SurgiCount+ System
Obstetrics & Gynecology
237d
Cleared
Sep 25, 2025
RPS Primary TKA Software
Orthopedic
91d
Cleared
Sep 09, 2025
PhotonBlade 3
Cardiovascular
202d
Cleared
May 15, 2025
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit)
Neurology
111d
Cleared
Apr 15, 2025
OptaBlate Radiofrequency (RF) Generator System
General & Plastic Surgery
69d
Cleared
Mar 24, 2025
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
General & Plastic Surgery
94d
Cleared
Mar 21, 2025
Consolidated Operating Room Equipment (CORE) 2 Console
Orthopedic
88d
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