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"
25–48 of 926
Search insights Median review: 90d Cleared: 100% Top manufacturer: Stryker Corp. Lead specialty: Orthopedic
Cleared Feb 18, 2026
1688 4K Camera System with Advanced Imaging Modality
K260185 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 28d
Cleared Feb 18, 2026
Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial...
K253637 · MBH
Howmedica Osteonics Corp., Dba...
Orthopedic · 91d
Cleared Feb 12, 2026
L12 LED Light Source with AIM
K260108 · OWN
Stryker Endoscopy
General & Plastic Surgery · 29d
Cleared Feb 11, 2026
AXS Lift Intracranial Base Catheter
K253032 · QJP
Stryker Neurovascular
Neurology · 142d
Cleared Feb 06, 2026
Spine Guidance 5.3 Software
K252871 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 149d
Cleared Feb 03, 2026
T2 Alpha Femur Retrograde Nailing System
K253640 · HSB
Stryker GmbH
Orthopedic · 76d
Cleared Jan 13, 2026
Connected OR Hub with Device and Voice Control
K254014 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 29d
Cleared Dec 31, 2025
MOLLI 2 System
K253888 · NEU
Stryker Endoscopy
General & Plastic Surgery · 27d
Cleared Dec 19, 2025
Hoffmann LRF System
K253202 · KTT
Stryker GmbH
Orthopedic · 84d
Cleared Dec 15, 2025
Triathlon® Tritanium® Asymmetric Patella
K252898 · KRO
Howmedica Osteonics Corp., Dba...
Orthopedic · 95d
Cleared Dec 11, 2025
Target Detachable Coil
K252694 · HCG
Stryker Neurovascular
Neurology · 107d
Cleared Oct 29, 2025
Synchfix EVT
K251643 · HTN
Wright Medical Technology, Inc....
Orthopedic · 153d
Cleared Oct 24, 2025
Triathlon® Total Knee System - Triathlon® Gold Femoral Components
K252044 · MBH
Howmedica Osteonics Corp., Dba...
Orthopedic · 116d
Cleared Oct 17, 2025
InZone IST Detachment System
K251832 · HCG
Stryker Neurovascular
Neurology · 123d
Cleared Sep 30, 2025
Allomatrix (Allomatrix Injectable Putty
K252085 · MQV
Wright Medical Technology, Inc....
Orthopedic · 90d
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 Aug 20, 2025
T2 Alpha Humerus Nailing System
K251400 · HSB
Stryker GmbH
Orthopedic · 106d
Cleared Aug 14, 2025
Reprocessed HARMONIC 700 Shears (HAR723/Reprocessed HARMONIC 700, 5mm...
K250898 · NLQ
Stryker Sustainability Solutions
General & Plastic Surgery · 142d
Cleared Aug 13, 2025
T2 Alpha Femur Retrograde Nailing System
K250163 · HSB
Stryker GmbH
Orthopedic · 204d
Cleared Jul 25, 2025
Triathlon® Hinge Knee System
K251665 · KRO
Howmedica Osteonics Corp., Dba...
Orthopedic · 56d
Cleared Jul 25, 2025
Stryker and Serf hip devices
K250989 · LPH
Howmedica Osteonics Corp., Dba...
Orthopedic · 116d
Cleared Jul 24, 2025
SPY Laparoscope
K252010 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 27d
Cleared Jul 18, 2025
SPY Cystoscope/Hysteroscope
K252012 · HIH
Stryker Endoscopy
Obstetrics & Gynecology · 21d