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
1–24 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Oct 26, 2026
GPS Ankle
K262567 · OLO
Blue Ortho
Orthopedic · 94d
Cleared Oct 19, 2026
7D Surgical System (10-0001)
K260403 · OLO
7D Surgical ULC
Orthopedic · 255d
Cleared Oct 16, 2026
TMINI Miniature Robotic System
K263234 · OLO
THINK Surgical, Inc.
Orthopedic · 30d
Cleared Oct 09, 2026
CarboClear® Cervical Navigated Instruments
K263154 · OLO
CarboFix Orhtopedics , Ltd.
Orthopedic · 30d
Cleared Sep 30, 2026
Spine Planning (3.0)
K262257 · OLO
Brainlab SE
Orthopedic · 90d
Cleared Aug 20, 2026
Remex Spine Surgery Navigation - Universal Instruments
K262506 · OLO
Remex Medical Corp.
Orthopedic · 30d
Cleared Jul 30, 2026
Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral...
K261410 · OLO
Suite 201, National Innovation Centre
Orthopedic · 91d
Cleared Jul 29, 2026
SPINEART Navigation Instrument System
K261205 · OLO
Spineart SA
Orthopedic · 107d
Cleared Jul 24, 2026
TMINI Miniature Robotic System
K261024 · OLO
THINK Surgical, Inc.
Orthopedic · 116d
Cleared Jul 24, 2026
Ion-L Navigated Instruments
K262121 · OLO
SurGenTec, LLC
Orthopedic · 31d
Cleared Jul 22, 2026
Op.n™ Spine Navigation and Robotic Guidance
K261113 · OLO
Ecential Robotics
Orthopedic · 110d
Cleared Jul 01, 2026
OTS Hip
K261852 · OLO
Ortoma AB
Orthopedic · 28d
Cleared Jun 26, 2026
VERTICALE® Navigation Instruments
K253921 · OLO
Silony Medical GmbH
Orthopedic · 200d
Cleared Jun 25, 2026
VELYS™ Robotic-Assisted Solution
K260480 · OLO
Depuy Ireland UC
Orthopedic · 132d
Cleared Jun 20, 2026
Dynamis Robotic Surgical System
K260369 · OLO
LEM Surgical AG
Orthopedic · 135d
Cleared Jun 18, 2026
CORUS™ Navigation System-GN
K261665 · OLO
Providence Medical Technology, Inc.
Orthopedic · 29d
Cleared Jun 02, 2026
SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
K260571 · OLO
Life Spine, Inc.
Orthopedic · 103d
Cleared May 29, 2026
Navigated LLIF Impactable Tracker
K261060 · OLO
Tyber Medical, LLC
Orthopedic · 59d
Cleared May 26, 2026
CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
K254157 · OLO
Medos International SARL
Orthopedic · 155d
Cleared May 22, 2026
Ion-C Navigation Instruments
K260329 · OLO
SurGenTec, LLC
Orthopedic · 112d
Cleared May 21, 2026
ROSA® Shoulder System
K260582 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 90d
Cleared May 11, 2026
Pytheas Your Guided Trajectory
K252880 · OLO
Pytheas Navigation Sas
Orthopedic · 243d
Cleared Apr 16, 2026
Foundation Surgical Navigated Lateral Disc Prep Instruments
K260011 · OLO
Foundation Surgical Group, Inc.
Orthopedic · 104d
Cleared Apr 09, 2026
SPINEART Navigation Instrument System
K254158 · OLO
Spineart SA
Orthopedic · 108d