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
97–120 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Jun 17, 2024
Robotic Integration Instruments
K233256 · OLO
DePuy Synthes
Orthopedic · 263d
Cleared Jun 14, 2024
Spine Navigation and Robotic-Assistance Device
K233228 · OLO
Ecential Robotics
Orthopedic · 260d
Cleared Jun 14, 2024
TELIGEN System Navigation Ready Instruments
K233254 · OLO
DePuy Synthes
Orthopedic · 260d
Cleared Jun 14, 2024
ExcelsiusFlex™
K240721 · OLO
Globus Medical, Inc.
Orthopedic · 88d
Cleared Jun 14, 2024
INNOVERSE Navigation Instruments
K241082 · OLO
Innosys Co., Ltd.
Orthopedic · 56d
Cleared Jun 11, 2024
Mako Total Knee Application
K241011 · OLO
Mako Surgical Corp.
Orthopedic · 60d
Cleared Jun 06, 2024
Spine Guidance Software (version 5.0)
K240662 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 90d
Cleared Jun 06, 2024
Invictus Robotic Navigation Instruments
K240951 · OLO
Alphatec Spine
Orthopedic · 59d
Cleared Jun 05, 2024
VELYS Robotic-Assisted Solution
K240211 · OLO
Depuy Ireland UC
Orthopedic · 132d
Cleared May 23, 2024
Drill Guide
K240701 · OLO
Brainlab AG
Orthopedic · 70d
Cleared May 03, 2024
CORUS Navigation Access System
K240625 · OLO
Providence Medical Technology, Inc.
Orthopedic · 58d
Cleared May 01, 2024
Remex Spine Surgery Navigation System II
K233513 · OLO
Remex Medical Corp.
Orthopedic · 182d
Cleared Apr 29, 2024
ARVIS® Shoulder
K240062 · OLO
Insight Medical Systems, Inc.
Orthopedic · 111d
Cleared Apr 29, 2024
DuraPro™ Oscillating System
K240568 · OLO
Globus Medical, Inc.
Orthopedic · 60d
Cleared Apr 05, 2024
Virage® Navigation System
K240647 · OLO
Zimvie Spine (Zimmer Biomet Spine, Inc.)
Orthopedic · 29d
Cleared Mar 29, 2024
Genesys Spine Sacroiliac Joint Fusion System with Navigation
K233595 · OLO
Genesys Spine
Orthopedic · 142d
Cleared Mar 20, 2024
Automatic Registration
K234047 · OLO
Brainlab AG
Orthopedic · 90d
Cleared Mar 18, 2024
Real Intelligence™ CORI™
K240139 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 60d
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