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
289–312 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Oct 08, 2019
Premia Spine XL Instruments
K191854 · OLO
Premia Spine, Ltd.
Orthopedic · 90d
Cleared Oct 01, 2019
Intellijoint® Navigation System
K191507 · OLO
Intellijoint Surgical, Inc.
Orthopedic · 117d
Cleared Sep 27, 2019
Precision Spine Navigation Instrumentation
K181606 · OLO
Precision Spine, Inc.
Orthopedic · 465d
Cleared Sep 24, 2019
Mako Total Hip Application, Mako Total Knee Application
K191998 · OLO
Mako Surgical Corp.
Orthopedic · 60d
Cleared Sep 20, 2019
INTAI Surgery Navigation System
K180523 · OLO
Intai Technology Corporation
Orthopedic · 570d
Cleared Aug 29, 2019
Spine & Trauma Navigation
K183605 · OLO
Brainlab AG
Orthopedic · 246d
Cleared Aug 26, 2019
Navigated T2 STRATOSPHERE Inserters and Navigated Templates
K191039 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 129d
Cleared Aug 07, 2019
Navigated Pedicle Access Kit
K191012 · OLO
Izi Medical Products, LLC
Orthopedic · 113d
Cleared Jul 24, 2019
ExcelsiusGPS Spine 1.1 Interbody Module
K191100 · OLO
Globus Medical, Inc.
Orthopedic · 90d
Cleared Jun 28, 2019
NAVIO
K191223 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 52d
Cleared Jun 17, 2019
GALILEO Spine Alignment Monitoring System
K182524 · OLO
MiRus, LLC
Orthopedic · 277d
Cleared Jun 11, 2019
Spine & Trauma Navigation
K191285 · OLO
Brainlab AG
Orthopedic · 29d
Cleared Jun 10, 2019
SPINEART Navigation Instrument System
K183630 · OLO
Spineart SA
Orthopedic · 166d
Cleared May 22, 2019
Stealth-Midas MR8 System
K183644 · OLO
Medtronic Powered Surgical Solutions
Orthopedic · 147d
Cleared May 17, 2019
Navigation Enabled Instruments
K183381 · OLO
Stryker
Orthopedic · 162d
Cleared Apr 09, 2019
ExcelsiusGPS
K190653 · OLO
Globus Medical, Inc.
Orthopedic · 26d
Cleared Mar 22, 2019
ROSA ONE Spine application
K182848 · OLO
Medtech S.A
Orthopedic · 164d
Cleared Feb 14, 2019
Stryker Navigation System with SpineMap Go Software Application, Fluoroscopy...
K183196 · OLO
Stryker Corporation
Orthopedic · 87d
Cleared Jan 24, 2019
ROSA Knee System
K182964 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 91d
Cleared Jan 08, 2019
Choice Spine Navigation System
K182721 · OLO
Choicespine, LP
Orthopedic · 102d
Cleared Jan 04, 2019
BridalVeil Navigated Instruments
K182982 · OLO
Astura Medical
Orthopedic · 67d
Cleared Nov 09, 2018
Brainlab Compatible K2M Navigation Instruments
K181890 · OLO
K2m
Orthopedic · 119d
Cleared Nov 02, 2018
Mazor X System (Mazor X Stealth Edition)
K182077 · OLO
Mazor Robotics , Ltd.
Orthopedic · 93d
Cleared Nov 02, 2018
NavLock Trackers, Robotic Reference Frame
K182104 · OLO
Medtronic Navigation
Orthopedic · 91d