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
97–120 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Jul 26, 2024
Spine Navigation System
K233725 · OLO
Medivis, Inc.
Orthopedic · 248d
Cleared Jul 25, 2024
Spine Guidance Software (Version 5.1)
K241171 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 90d
Cleared Jul 24, 2024
“POINT” Kinguide Agile Hybrid Navigation System (PSHF01-000)
K241130 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 91d
Cleared Jul 12, 2024
TMINI Miniature Robotic System (TMINI 1.1)
K241031 · OLO
THINK Surgical, Inc.
Orthopedic · 88d
Cleared Jul 05, 2024
Anatase Navi Disposable Instrument
K241625 · OLO
Remex Medical Corp.
Orthopedic · 29d
Cleared Jun 17, 2024
CROSSNAV Navigation Enabled Instruments
K233255 · OLO
DePuy Synthes
Orthopedic · 263d
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