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

Filters: OLO ×
439 results
121–144 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
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
Cleared Jul 20, 2023
ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation...
K223301 · OLO
Spinecraft, LLC
Orthopedic · 266d
Cleared Jul 18, 2023
Robotic Graft Delivery Instruments
K230716 · OLO
Medtronic Sofamor Danek, Inc.
Orthopedic · 125d
Cleared Jul 17, 2023
“POINT” Kinguide Agile Hybrid Navigation System
K230087 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 186d
Cleared Jul 12, 2023
Zavation Navigation Instrument System
K223808 · OLO
Zavation Medical Products, LLC
Orthopedic · 204d
Cleared Jun 27, 2023
VADER® Pedicle System Navigated Instruments
K230861 · OLO
Icotec AG
Orthopedic · 90d
Cleared Jun 27, 2023
RI.KNEE Adjustable Tibia Cut Guide
K230876 · OLO
Enztec Limited
Orthopedic · 89d