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
361–384 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Mar 13, 2017
Navigated Instrument System
K162921 · OLO
Orthofix, Inc.
Orthopedic · 146d
Cleared Mar 06, 2017
TSolution One Surgical System Model 210
K170430 · OLO
THINK Surgical, Inc.
Orthopedic · 21d
Cleared Mar 02, 2017
Intellijoint HIP Generation 2A System
K162364 · OLO
Intellijoint Surgical, Inc.
Orthopedic · 191d
Cleared Mar 02, 2017
KneeAlign 2 System
K163379 · OLO
Orthalign, Inc.
Orthopedic · 91d
Cleared Feb 23, 2017
Stryker OrthoMap Versatile Hip System
K162937 · OLO
Stryker Corporation
Orthopedic · 126d
Cleared Jan 23, 2017
OrthAlign Plus System
K162962 · OLO
Orthalign, Inc.
Orthopedic · 91d
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