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
361–384 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Dec 29, 2016
Envision 3D: Image Guidance System
K162375 · OLO
7D Surgical, Inc.
Orthopedic · 127d
Cleared Oct 12, 2016
Stryker OrthoMap Precision Knee system
K162341 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 51d
Cleared Sep 14, 2016
TSolution One Cup1 Surgical System
K162195 · OLO
THINK Surgical, Inc.
Orthopedic · 40d
Cleared Jul 27, 2016
Precision Screw
K160385 · OLO
Cryptych Pty, Ltd.
Orthopedic · 167d
Cleared Jul 08, 2016
Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments
K153700 · OLO
Aesculap Implant Systems, LLC
Orthopedic · 198d
Cleared Jul 07, 2016
Styrker OrthoMap Express Knee System
K153240 · OLO
Stryker Corporate
Orthopedic · 241d
Cleared May 26, 2016
Stealth-Midas System
K160713 · OLO
Medtronic Powered Surgical Solutions
Orthopedic · 72d
Cleared May 19, 2016
Navio
K160537 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 83d
Cleared May 16, 2016
Aesculap OrthoPilot Next Generation
K153396 · OLO
Aesculap Implant Systems, LLC
Orthopedic · 174d
Cleared Apr 29, 2016
Alphatec Navigation Instruments
K153603 · OLO
Alphatec Spine, Inc.
Orthopedic · 134d
Cleared Mar 01, 2016
OrthAlign Plus System
K153237 · OLO
Orthalign, Inc.
Orthopedic · 113d
Cleared Feb 16, 2016
TSolution One w/ACG+ Surgical System
K153647 · OLO
THINK Surgical, Inc.
Orthopedic · 57d
Cleared Feb 03, 2016
Navigation Instruments
K153203 · OLO
Globus Medical, Inc.
Orthopedic · 91d
Cleared Jan 04, 2016
ROSA Spine
K151511 · OLO
Medtech S.A
Orthopedic · 214d
Cleared Dec 28, 2015
Intellijoint HIP(tm) System
K151364 · OLO
Intellijoint Surgical, Inc.
Orthopedic · 221d
Cleared Nov 17, 2015
Renaissance X System
K152041 · OLO
Mazor Robotics , Ltd.
Orthopedic · 118d
Cleared Oct 20, 2015
Navio
K152574 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 41d
Cleared Sep 16, 2015
Partial Knee Application (PKA)
K142530 · OLO
Mako Surgical Corporation
Orthopedic · 372d
Cleared Sep 04, 2015
Navigated XIA 4.5 Polyaxial Screwdriver
K143597 · OLO
Stryker Corporate
Orthopedic · 260d
Cleared Aug 06, 2015
Total Knee Application (TKA)
K143752 · OLO
Mako Surgical Corp.
Orthopedic · 218d
Cleared Jun 16, 2015
Navigated Disc Prep Instruments and CAPSTONE Trials
K150231 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 134d
Cleared Mar 20, 2015
Navio
K143668 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 86d
Cleared Feb 24, 2015
AESCULAP ORTHOPILOT NEXT GENERATION
K141694 · OLO
Aesculap Implant Systems, LLC
Orthopedic · 245d
Cleared Feb 12, 2015
Navigated Vertex Select Instruments
K143628 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 52d