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

90 results for "Stryker Corporation"
1–24 of 90
Search insights Median review: 97d Cleared: 100% Top manufacturer: Stryker Corporation Lead specialty: Orthopedic
Cleared Jun 12, 2026
Tornier Perform Reversed Glenoid and Tornier Perform Reversed Augmented...
K260102 · PHX
Stryker Corporation (Tornier, Inc.)
Orthopedic · 150d
Cleared Apr 03, 2026
Blueprint Patient-Specific Instrumentation
K253674 · PHX
Stryker Corporation (Tornier, S.A.S.)
Orthopedic · 133d
Cleared Oct 29, 2025
Synchfix EVT
K251643 · HTN
Wright Medical Technology, Inc....
Orthopedic · 153d
Cleared Sep 30, 2025
Allomatrix (Allomatrix Injectable Putty
K252085 · MQV
Wright Medical Technology, Inc....
Orthopedic · 90d
Cleared Dec 06, 2024
Tornier Humeral Reconstruction System (Tornier HRS)
K241878 · KWS
Stryker Corporation (Tornier, Inc.)
Orthopedic · 161d
Cleared Oct 10, 2024
Blueprint Patient-Specific Instrumentation
K241491 · PHX
Stryker Corporation (Tornier, S.A.S.)
Orthopedic · 139d
Cleared Sep 10, 2024
Tornier Humeral Reconstruction System (Tornier HRS)
K241609 · KWS
Stryker Corporation (Tornier, Inc.)
Orthopedic · 97d
Cleared Aug 18, 2023
Connected OR Hub with Device and Voice Control, SDC4K Information Management...
K232157 · GCJ
Stryker Corporation
General & Plastic Surgery · 29d
Cleared Feb 16, 2023
Sonopet 1Q 3 7cm 1Q Large
K223770 · LFL
Stryker Corporation
General & Plastic Surgery · 63d
Cleared Feb 16, 2023
Stryker Q Guidance System with Cranial Guidance Software, CranialMask Tracker...
K212194 · HAW
Stryker Corporation
Neurology · 582d
Cleared Oct 19, 2022
Aviator® Anterior Cervical Plating (ACP) System, LITe® Plate System,...
K221728 · KWQ
Stryker Corporation
Orthopedic · 127d
Cleared Sep 16, 2022
OptaBlate RF Generator, OptaBlate Probes, OptaBlate Microinfuser Infusion...
K221074 · GEI
Stryker Corporation
General & Plastic Surgery · 157d
Cleared Jul 12, 2022
Scopis ENT Software, Scopis ENT Software with TGS, Scopis Planning Software,...
K221098 · PGW
Stryker Corporation
Ear, Nose, Throat · 89d
Cleared Feb 03, 2022
Sonopet iQ Ultrasonic Aspirator System
K213824 · LFL
Stryker Corporation
General & Plastic Surgery · 57d
Cleared Dec 16, 2021
Connected OR Hub with Device and Voice Control
K212055 · GCJ
Stryker Corporation
General & Plastic Surgery · 168d
Cleared Jun 30, 2021
Stryker iBur hubs and cutting accessories
K210377 · HBE
Stryker Corporation
Neurology · 141d
Cleared Jun 18, 2021
iBed Wireless with iBed Mobile
K202964 · FNL
Stryker Corporation
General Hospital · 261d
Cleared Jun 09, 2021
Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model...
K211490 · ERL
Stryker Corporation
Ear, Nose, Throat · 27d
Cleared Oct 20, 2020
SpineJack Expansion Kit
K202393 · NDN
Stryker Corporation
Orthopedic · 60d
Cleared Oct 09, 2020
Instrument Clamps Electromagnetic
K202609 · PGW
Stryker Corporation
Ear, Nose, Throat · 30d
Cleared Aug 10, 2020
Monterey AL Interbody System
K201585 · OVD
Stryker Corporation
Orthopedic · 60d
Cleared Apr 15, 2020
Tritanium® X TL Expandable Curved Posterior Lumbar Cage
K200613 · MAX
Stryker Corporation
Orthopedic · 37d
Cleared Mar 31, 2020
Vertaplex HV High Viscosity Radiopaque Bone Cement
K192818 · PML
Stryker Corporation
Orthopedic · 182d
Cleared Mar 21, 2020
Stryker T7 Surgical Hoods, Stryker T7 Surgical Togas, Zippered, Stryker T7...
K200493 · FXY
Stryker Corporation
General Hospital · 22d