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
385–408 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Sep 04, 2015
Navigated XIA 4.5 Polyaxial Screwdriver
K143597 · OLO
Stryker Corporate
Orthopedic · 260d
Cleared CT 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
Cleared Nov 13, 2014
MAKOPLASTY TOTAL HIP ALLPICATION, RIO STANDARD SYSTEM
K141989 · OLO
Mako Surgical Corporation
Orthopedic · 114d
Cleared Oct 31, 2014
SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE,...
K141941 · OLO
Stryker Corporate
Orthopedic · 106d
Cleared Oct 24, 2014
UNIVERSAL NAVIGATION INSTRUMENTS
K140927 · OLO
Medos International SARL
Orthopedic · 196d
Cleared Sep 11, 2014
IASSIST KNEE SYSTEM
K141601 · OLO
Zimmer Cas
Orthopedic · 87d
Cleared Sep 10, 2014
RENAISSANCE X SYSTEM
K140167 · OLO
Mazor Robotics , Ltd.
Orthopedic · 230d
Cleared Aug 22, 2014
IKNEE DISTAL FEMORAL CUTTING GUIDE
K140689 · OLO
Evergreen Orthopedic Research Lab
Orthopedic · 156d
Cleared Jul 23, 2014
INTELLIJOINT HIP
K133759 · OLO
Intellijoint Surgical, Inc.
Orthopedic · 224d
Cleared Jul 02, 2014
NAVIO
K140596 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 117d
Cleared Jun 10, 2014
ORTHALIGN PLUS SYSTEM
K140331 · OLO
Orthalign, Inc.
Orthopedic · 120d
Cleared May 22, 2014
NAVIGATED CD HORIZON SOLERA SCREWDRIVER/TAPS
K140454 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d
Cleared Nov 08, 2013
ORTHOALIGN PLUS SYSTEM
K130387 · OLO
Orthalign, Inc.
Orthopedic · 266d
Cleared Aug 14, 2013
NAVIGATED CAPSTONE TRIALS, CLYDESDALE TRIALS, CAPSTONE & CLYDESDALE INSERTER
K131425 · OLO
Medtronic Navigation, Inc.
Orthopedic · 89d
Cleared Aug 13, 2013
S4C NAVIGATION INSTRUMENTS
K130887 · OLO
Aesculap Implant System, Inc.
Orthopedic · 137d
Cleared Aug 04, 2013
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V3.0
K130748 · OLO
Smith & Nephew, Inc.
Orthopedic · 138d
Cleared Jul 19, 2013
NAVIGATION PIN
K131130 · OLO
Evergreen Orthopedic Research Lab
Orthopedic · 87d
Cleared Mar 22, 2013
NAVIGATED CD HORIZON SOLERA SCREWDRIVERS, TAPS, ILIAC TAPS, LEGACY TAPS
K124004 · OLO
Medtronic Navigation, Inc.
Orthopedic · 86d
Cleared Jan 11, 2013
SCULPTOR ROBOTIC GUIDANCE ARM (RGA)
K121765 · OLO
Stanmore Implants Worldwide , Ltd.
Orthopedic · 210d
Cleared Dec 07, 2012
NUVASIVE BENDINI SPINAL ROD BENDING SYSTEM
K122742 · OLO
Nuvasive, Inc.
Orthopedic · 91d