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"
49–72 of 926
Search insights Median review: 90d Cleared: 100% Top manufacturer: Stryker Corp. Lead specialty: Orthopedic
Cleared Jun 20, 2025
Incompass Total Ankle System
K250037 · HSN
Wright Medical Technology, Inc....
Orthopedic · 163d
Cleared May 23, 2025
Knotilus+ Biocomposite Knotless Anchor
K250544 · MAI
Stryker Endoscopy
Orthopedic · 87d
Cleared May 21, 2025
Stryker AlphaVent™ Knotless SP Biocomposite Anchor
K250528 · MAI
Stryker Endoscopy
Orthopedic · 86d
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 21, 2025
Excelsior XT-27 Microcatheter, Excelsior XT-27 Flex Microcatheter, Excelsior...
K242289 · QJP
Stryker Neurovascular
Neurology · 231d
Cleared Mar 11, 2025
iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D)
K250374 · HBE
Stryker Instruments
Neurology · 29d
Cleared Feb 18, 2025
AXS Lift Intracranial Base Catheter
K243593 · QJP
Stryker Neurovascular
Neurology · 90d
Cleared Feb 06, 2025
Scorpio Universal Dome Patella
K243817 · JWH
Howmedica Osteonics Corp., Dba...
Orthopedic · 56d
Cleared Feb 06, 2025
Stryker Orthopaedics Hip Devices Labeling Update
K243784 · LPH
Howmedica Osteonics Corp., Dba...
Orthopedic · 59d
Cleared Jan 16, 2025
System 9 Sterile Battery Container
K242834 · KCT
Stryker Instruments
General Hospital · 119d
Cleared Dec 19, 2024
Broadway 8 Catheter
K241768 · QJP
Stryker Neurovascular
Neurology · 182d
Cleared Dec 19, 2024
Echo Intracranial Base Catheter
K241637 · QJP
Stryker Neurovascular
Neurology · 195d
Cleared Dec 11, 2024
SternalPlate Expansion
K243491 · HRS
Stryker Leibinger GmbH & Co KG
Orthopedic · 29d
Cleared Dec 06, 2024
Tornier Humeral Reconstruction System (Tornier HRS)
K241878 · KWS
Stryker Corporation (Tornier, Inc.)
Orthopedic · 161d
Cleared Dec 04, 2024
Triathlon Knee System
K242831 · JWH
Howmedica Osteonics Corp., Dba...
Orthopedic · 76d
Cleared Nov 07, 2024
OZARK Cervical Plate System
K242361 · KWQ
Stryker Spine
Orthopedic · 90d
Cleared Nov 01, 2024
Prophecy Surgical Planning System
K241999 · HSN
Wright Medical Technology, Inc....
Orthopedic · 115d
Cleared Oct 22, 2024
Reprocessed RD SET Adt Pulse Oximeter Sensor (4000)
K241758 · NLF
Stryker Sustainability Solutions
Anesthesiology · 124d
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 Oct 10, 2024
Blueprint Patient-Specific Instrumentation
K241491 · PHX
Stryker Corporation (Tornier, S.A.S.)
Orthopedic · 139d