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
337–360 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Sep 15, 2017
Mazor X
K172522 · OLO
Mazor Robotics , Ltd.
Orthopedic · 25d
Cleared Sep 14, 2017
VIPER PRIME navigated inserter
K170937 · OLO
Medos International SARL
Orthopedic · 168d
Cleared Sep 01, 2017
OMNIBotics Knee System
K163338 · OLO
Omnllife Science, Inc.
Orthopedic · 277d
Cleared Aug 30, 2017
K2M Navigation Instruments
K171321 · OLO
K2m
Orthopedic · 118d
Cleared Aug 16, 2017
EXCELSIUS GPS
K171651 · OLO
Globus Medical, Inc.
Orthopedic · 72d
Cleared Jul 11, 2017
OrthAlign Plus System
K171780 · OLO
Orthalign, Inc.
Orthopedic · 26d
Cleared Jul 03, 2017
NavLock Trackers
K171267 · OLO
Medtronic Navigation
Orthopedic · 63d
Cleared May 24, 2017
Mako Partial Knee Application
K170891 · OLO
Mako Surgical Corp.
Orthopedic · 58d
Cleared May 11, 2017
Mako Total Knee Application
K170581 · OLO
Mako Surgical Corp.
Orthopedic · 72d
Cleared May 11, 2017
Mako Partial Knee Application
K170584 · OLO
Mako Surgical Corp.
Orthopedic · 72d
Cleared May 03, 2017
SURESHOT Distal Targeting System V4.0 Trauma Interface
K170977 · OLO
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared May 02, 2017
NAVIO
K170360 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 85d
Cleared May 01, 2017
StealthStation S8 Spine Software v1.0.0
K170011 · OLO
Medtronic Navigation
Orthopedic · 118d
Cleared Apr 28, 2017
Smith & Nephew SURESHOT Distal Targeting System V4.0
K170280 · OLO
Smith & Nephew, Inc.
Orthopedic · 88d
Cleared Apr 18, 2017
Mako Total Hip Application
K170593 · OLO
Mako Surgical Corp.
Orthopedic · 49d
Cleared Apr 14, 2017
Navigated ELEVATE Inserter, Navigated Disc Prep Instruments
K163581 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 115d
Cleared Apr 05, 2017
ExactechGPS Total Shoulder Application, Equinoxe Planning Software
K162567 · OLO
Blue Ortho
Orthopedic · 203d
Cleared Apr 04, 2017
Mazor X
K163221 · OLO
Mazor Robotics , Ltd.
Orthopedic · 139d
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