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

Filters: OLO ×
445 results
121–144 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Mar 14, 2024
Ortho Guidance Precision Knee Software
K233542 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 132d
Cleared Mar 11, 2024
OTS Hip
K232140 · OLO
Ortoma AB
Orthopedic · 237d
Cleared Mar 08, 2024
Neo ADVISE software
K230195 · OLO
Comerge AG
Orthopedic · 408d
Cleared Feb 23, 2024
Navigation Tracking Instruments
K232800 · OLO
SI-BONE, Inc.
Orthopedic · 164d
Cleared Feb 21, 2024
ROSA® Shoulder System
K233199 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 146d
Cleared Feb 09, 2024
VERZA™ High Speed Drills
K233638 · OLO
Globus Medical, Inc.
Orthopedic · 88d
Cleared Jan 26, 2024
ExactechGPS® System
K233299 · OLO
Blue Ortho
Orthopedic · 119d
Cleared Dec 14, 2023
VELYS™ Robotic-Assisted Solution
K233227 · OLO
Depuy Ireland UC
Orthopedic · 77d
Cleared Dec 13, 2023
Kalitec Navigated Instrument System
K232572 · OLO
Kalitec Direct, LLC Doing Business AS...
Orthopedic · 111d
Cleared Nov 20, 2023
RIWOtrack Navigation System
K230700 · OLO
Fiagon GmbH
Orthopedic · 252d
Cleared Nov 16, 2023
ExactechGPS® Total Ankle Application
K232521 · OLO
Blue Ortho
Orthopedic · 90d
Cleared Nov 16, 2023
ROSA Partial Knee System
K232533 · OLO
Orthosoft D/B/A Zimmer Cas
Orthopedic · 87d
Cleared Nov 16, 2023
Vital™ Navigation System
K233443 · OLO
Zimvie Spine (Zimmer Biomet Spine, Inc.)
Orthopedic · 28d
Cleared Nov 02, 2023
ATEC Posterior Navigated Disc Prep Instruments
K232345 · OLO
Alphatec Spine, Inc.
Orthopedic · 90d
Cleared Oct 27, 2023
CoreLink Robotic Navigation Instruments
K231494 · OLO
Corelink, LLC
Orthopedic · 157d
Cleared Oct 12, 2023
TMINI™ Miniature Robotic System
K232802 · OLO
THINK Surgical, Inc.
Orthopedic · 30d
Cleared Oct 06, 2023
Invictus Robotic Navigation Instruments
K232044 · OLO
Alphatec Spine, Inc.
Orthopedic · 88d
Cleared Sep 29, 2023
TriALTIS Navigation Enabled Instruments
K231527 · OLO
Medos International S?rl
Orthopedic · 126d
Cleared Sep 08, 2023
Fusion Robotic Navigation System
K232413 · OLO
Alphatec Spine, Inc.
Orthopedic · 29d
Cleared Aug 16, 2023
CoreLink Navigation Instruments
K232116 · OLO
Corelink, LLC
Orthopedic · 30d
Cleared Aug 02, 2023
Spine Planning (2.0), Elements Spine Planning, Elements Planning Spine
K223553 · OLO
Brainlab AG
Orthopedic · 250d
Cleared Aug 01, 2023
REAL INTELLIGENCE™ CORI™
K231963 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 29d
Cleared Jul 27, 2023
SURGIVISIO Device
K231886 · OLO
Ecential Robotics
Orthopedic · 30d
Cleared Jul 26, 2023
ApolloKnee
K231172 · OLO
Corin U.S.A. Limited
Orthopedic · 92d