Stryker Instruments is one of 5511 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: Hydro Irrigation System, SurgiCount+ System, RPS Primary TKA Software
73
Total
73
Cleared
0
Denied
Stryker Instruments has 73 FDA 510(k) cleared medical devices. Based in Kalamazoo, US.
Latest FDA clearance: May 2026. Active since 1994.
Browse the FDA 510(k) cleared devices submitted by Stryker Instruments Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Stryker Instruments
73 devices
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
Cleared
Mar 11, 2025
iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D)
Neurology
29d
Cleared
Jan 16, 2025
System 9 Sterile Battery Container
General Hospital
119d
Cleared
Oct 21, 2024
PhotonBlade 3
General & Plastic Surgery
81d
Cleared
Oct 16, 2024
Stryker Steri-Shield 8 Surgical Hoods and Togas
General Hospital
163d
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