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

926 results for "Stryker"
1–24 of 926
Search insights Median review: 90d Cleared: 100% Top manufacturer: Stryker Corp. Lead specialty: Orthopedic
Cleared Oct 20, 2026
SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000)
K262386 · GEI
Stryker Instruments
General & Plastic Surgery · 99d
Cleared Oct 09, 2026
Excelsior Reach Microcatheter
K261649 · QJP
Stryker Neurovascular
Neurology · 143d
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 Aug 06, 2026
Triathlon® Knee System
K261898 · KRO
Howmedica Osteonics Corp., Dba...
Orthopedic · 62d
Cleared Jul 30, 2026
AIR+ All-Inside Meniscal Repair Device, Curved Up
K262369 · MBI
Stryker Endoscopy
Orthopedic · 20d
Cleared Jul 17, 2026
Tritanium® C Anterior Cervical Cage
K262061 · ODP
Stryker Spine
Orthopedic · 29d
Not Cleared Jul 17, 2026
SportSuite Vision Software
DEN250040 · SIT
Stryker Endoscopy
Orthopedic · 318d
Cleared Jul 10, 2026
Omnifit® 20° Series I Insert
K261624 · LPH
Howmedica Osteonics Corp., Dba...
Orthopedic · 56d
Cleared Jul 01, 2026
Trevo Trak 21 Microcatheter
K261889 · QJP
Stryker Neurovascular
Neurology · 26d
Cleared Jul 01, 2026
RibPlate System
K261054 · HRS
Stryker Leibinger GmbH & Co KG
Orthopedic · 92d
Cleared Jun 24, 2026
Target Xtra Detachable Coil
K261772 · HCG
Stryker Neurovscular
Neurology · 26d
Cleared Jun 18, 2026
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
K260636 · GEI
Stryker Sustainability Solutions
General & Plastic Surgery · 112d
Cleared Jun 17, 2026
Hydro Irrigation System
K261544 · EOB
Stryker Instruments
Ear, Nose, Throat · 40d
Cleared Jun 16, 2026
Prophecy Incompass Surgical Planning System
K253159 · HSN
Wright Medical Technology, Inc....
Orthopedic · 263d
Cleared Jun 12, 2026
Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented...
K260102 · PHX
Stryker Corporation (Tornier, Inc.)
Orthopedic · 150d
Cleared Jun 04, 2026
Precision S 4K Sinuscope
K253602 · GWG
Stryker Endoscopy
Neurology · 198d
Cleared May 28, 2026
780 nm SPY Portable Handheld Imaging (SPY-PHI) System
K261037 · IZI
Stryker Endoscopy
General & Plastic Surgery · 59d
Cleared May 08, 2026
Hydro Irrigation System
K253679 · GWG
Stryker Instruments
Neurology · 168d
Cleared Apr 24, 2026
Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip
K261008 · MQV
Stryker Spine
Orthopedic · 29d
Cleared Apr 03, 2026
Blueprint Patient-Specific Instrumentation
K253674 · PHX
Stryker Corporation (Tornier, S.A.S.)
Orthopedic · 133d
Cleared Mar 16, 2026
SurgiCount+ System
K252282 · PBZ
Stryker Instruments
Obstetrics & Gynecology · 237d
Cleared Mar 12, 2026
MEDPOR Customized Implant Kit
K254233 · FWP
Stryker Leibinger GmbH & Co KG
General & Plastic Surgery · 73d
Cleared Feb 19, 2026
Spine Guidance 5.4 Software
K253623 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 93d