FDA 510(k) Searchable Database - Search 174,000+ Clearances

Search 174,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code — with real review time data, denied submission rates and regulatory intelligence no other searchable 510(k) database provides.

175,730 clearances · 1976 to present · Updated monthly from FDA records

919 results for "stryker"
49–72 of 919
Search insights Median review: 90d Cleared: 100% Top manufacturer: Stryker Corp. Lead specialty: Orthopedic
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
Cleared Oct 06, 2024
Pangea Platform
K242445 · HRS
Stryker GmbH
Orthopedic · 51d
Cleared Sep 10, 2024
Tornier Humeral Reconstruction System (Tornier HRS)
K241609 · KWS
Stryker Corporation (Tornier, Inc.)
Orthopedic · 97d
Cleared Aug 29, 2024
Vitoss® BiModal Bioactive Bone Graft Substitute Foam Strip, Vitoss® BiModal...
K242280 · MQV
Stryker Spine
Orthopedic · 27d
Cleared Aug 29, 2024
Target Detachable Coils
K242243 · HCG
Stryker Neurovscular
Neurology · 29d
Cleared Aug 27, 2024
Q Guidance System
K241517 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 90d