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
385–408 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
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
Cleared Nov 30, 2012
NAVIOPFS
K121936 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 151d
Cleared Nov 30, 2012
SMARTTOOLS KNEE SYSTEM
K122326 · OLO
Zimmer
Orthopedic · 121d
Cleared Nov 15, 2012
NAVIGATION SOFTWARE HIP-UNIVERSAL
K122011 · OLO
Brainlab AG
Orthopedic · 129d
Cleared Sep 20, 2012
VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS
K120867 · OLO
Medos International SARL
Orthopedic · 182d
Cleared Jun 06, 2012
MAKOPLASTY TOTAL HIP APPLICATION, RIO STANDARD SYSTEM
K121064 · OLO
Mako Surgical Corporation
Orthopedic · 61d
Cleared Mar 01, 2012
RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM
K112507 · OLO
Mako Surgical Corporation
Orthopedic · 184d