Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

83 results for "Stryker Instruments"
1–24 of 83
Search insights Median review: 88d Cleared: 100% Top manufacturer: Stryker Instruments Lead specialty: General & Plastic Surgery
Cleared Oct 20, 2026
SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000)
K262386 · GEI
Stryker Instruments
General & Plastic Surgery · 99d
Cleared Oct 08, 2026
Sonopet iQ Series III Console (5700-050-000)
K262244 · LFL
Stryker Instruments
General & Plastic Surgery · 99d
Cleared Sep 17, 2026
Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade,...
K261959 · GEI
Stryker Instruments
General & Plastic Surgery · 98d
Cleared Jun 17, 2026
Hydro Irrigation System
K261544 · EOB
Stryker Instruments
Ear, Nose, Throat · 40d
Cleared May 08, 2026
Hydro Irrigation System
K253679 · GWG
Stryker Instruments
Neurology · 168d
Cleared Mar 16, 2026
SurgiCount+ System
K252282 · PBZ
Stryker Instruments
Obstetrics & Gynecology · 237d
Cleared Sep 25, 2025
RPS Primary TKA Software
K251971 · OLO
Stryker Instruments
Orthopedic · 91d
Cleared Sep 09, 2025
PhotonBlade 3
K250483 · GEI
Stryker Instruments
Cardiovascular · 202d
Cleared May 15, 2025
OptaBlate BVN Intraosseous Nerve Ablation System (10mm Probe Single Kit)
K250213 · GXI
Stryker Instruments
Neurology · 111d
Cleared Apr 15, 2025
OptaBlate Radiofrequency (RF) Generator System
K250327 · GEI
Stryker Instruments
General & Plastic Surgery · 69d
Cleared Mar 24, 2025
Sonopet iQ Ultrasonic Aspirator System (5500-050-000)
K243930 · LFL
Stryker Instruments
General & Plastic Surgery · 94d
Cleared Mar 21, 2025
Consolidated Operating Room Equipment (CORE) 2 Console
K243958 · OLO
Stryker Instruments
Orthopedic · 88d
Cleared Mar 11, 2025
iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D)
K250374 · HBE
Stryker Instruments
Neurology · 29d
Cleared Jan 16, 2025
System 9 Sterile Battery Container
K242834 · KCT
Stryker Instruments
General Hospital · 119d
Cleared Oct 21, 2024
PhotonBlade 3
K242266 · GEI
Stryker Instruments
General & Plastic Surgery · 81d
Cleared Oct 16, 2024
Stryker Steri-Shield 8 Surgical Hoods and Togas
K241272 · FYA
Stryker Instruments
General Hospital · 163d
Cleared Apr 29, 2024
POWEReam Xia/Serrato
K240526 · NKB
Stryker Instruments
Orthopedic · 66d
Cleared Jan 11, 2024
SurgiCount+ System
K232250 · PBZ
Stryker Instruments
General & Plastic Surgery · 167d
Cleared Dec 26, 2023
POWEReam 1/4 Drive
K233300 · NKB
Stryker Instruments
Orthopedic · 88d
Cleared Dec 20, 2022
SpineJack® Expansion Kit
K223294 · NDN
Stryker Instruments
Orthopedic · 55d
Cleared Dec 09, 2022
120V Neptune S Rover (0711-001-000)
K222552 · JCX
Stryker Instruments
General & Plastic Surgery · 108d
Cleared Jun 25, 2021
SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV...
K211238 · NDN
Stryker Instruments
Orthopedic · 60d
Cleared Aug 22, 2017
Stryker Integrated Bipolar Cord and Tubing Sets
K172367 · GEI
Stryker Instruments
General & Plastic Surgery · 18d
Cleared Mar 28, 2013
STRYKER VENOM ELECTRODES AND CANNULAE
K123178 · GXI
Stryker Instruments, Instruments Div.
Neurology · 170d