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"
73–96 of 926
Search insights Median review: 90d Cleared: 100% Top manufacturer: Stryker Corp. Lead specialty: Orthopedic
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
Cleared Aug 15, 2024
Connected OR Hub with Device and Voice Control
K241401 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 90d
Cleared Aug 02, 2024
Global Modular Replacement System, Modular Replacement System, Modular...
K241716 · JDI
Howmedica Osteonics Corp., Dba...
Orthopedic · 49d
Cleared Jul 25, 2024
Spine Guidance Software (Version 5.1)
K241171 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 90d
Cleared Jul 12, 2024
MRI Universal
K240651 · JEY
Stryker Leibinger GmbH & Co KG
Dental · 127d
Cleared Jul 03, 2024
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm Length (HAR1120)
K241606 · NLQ
Stryker Sustainability Solutions
General & Plastic Surgery · 29d
Cleared Jun 06, 2024
Spine Guidance Software (version 5.0)
K240662 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 90d
Cleared May 07, 2024
LIFEPAK® ECG Cables
K240377 · DSA
Stryker Physio-Control
Cardiovascular · 90d
Cleared Apr 29, 2024
POWEReam Xia/Serrato
K240526 · NKB
Stryker Instruments
Orthopedic · 66d
Cleared Apr 24, 2024
22.2mm BIOLOX® delta Ceramic V40™ Femoral Heads
K234025 · LZO
Howmedica Osteonics Corp., Dba...
Orthopedic · 126d
Cleared Apr 19, 2024
LIFEPAK® 35 AC Power Adapter (41335-000001)
K240162 · MPD
Stryker Physio-Control
Cardiovascular · 88d
Cleared Apr 12, 2024
Stryker Orthopaedics Hip Systems Labeling Update
K240418 · JDI
Howmedica Osteonics Corp., Dba...
Orthopedic · 59d
Cleared Mar 25, 2024
VariAx 2 Distal Radius System
K233919 · HRS
Stryker GmbH
Orthopedic · 103d
Cleared Mar 14, 2024
Ortho Guidance Precision Knee Software
K233542 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 132d
Cleared Mar 11, 2024
28mm/38D MDM X3 Insert for MDM Liner
K233724 · LZO
Howmedica Osteonics Corp., Dba...
Orthopedic · 111d
Cleared Mar 07, 2024
ICONIX All-Suture Anchor
K240407 · MBI
Stryker Endoscopy
Orthopedic · 27d
Cleared Feb 22, 2024
1688 4K Camera System with Advanced Imaging Modality
K240174 · GCJ
Stryker Endoscopy
General & Plastic Surgery · 30d
Cleared Feb 20, 2024
Reprocessed HARMONIC 1100 Shears, 5mm Diameter, 20cm length (HAR1120)
K233471 · NLQ
Stryker Sustainability Solutions
General & Plastic Surgery · 118d
Cleared Feb 12, 2024
SPY Cystoscope/Hysteroscope
K233635 · HIH
Stryker Endoscopy
Obstetrics & Gynecology · 91d
Cleared Jan 25, 2024
AlphaVent Knotless SP PEEK Anchor
K233893 · MBI
Stryker Endoscopy
Orthopedic · 48d