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
289–312 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
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
Cleared Nov 02, 2018
CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
K182121 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Oct 24, 2018
Spine Wave Navigated Instruments
K181596 · OLO
Spine Wave, Inc.
Orthopedic · 128d
Cleared Oct 12, 2018
ADAPT for Gamma3, Gamma3
K181848 · OLO
Stryker GmbH
Orthopedic · 93d
Cleared Sep 21, 2018
Spineology Navigation Instruments
K182345 · OLO
Spineology, Inc.
Orthopedic · 24d
Cleared Sep 19, 2018
Ortoma Treatment Solution - OTS
K181449 · OLO
Ortoma AB
Orthopedic · 110d
Cleared Jul 11, 2018
Ziehm RFD 3D Tracker
K180816 · OLO
Medtronic Navigation
Orthopedic · 104d