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
337–360 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Nov 16, 2017
Intellijoint HIP System (Cart), Intellijoint HIP System (Portable),...
K172849 · OLO
Intellijoint Surgical, Inc.
Orthopedic · 57d
Cleared Nov 02, 2017
Mako Partial Knee Application
K172301 · OLO
Mako Surgical Corp.
Orthopedic · 94d
Cleared Oct 31, 2017
iFuse Implant System- iFuse Navigation
K172268 · OLO
SI-BONE, Inc.
Orthopedic · 96d
Cleared Oct 30, 2017
Intellijoint HIP Generation 2B System
K171525 · OLO
Intellijoint Surgical, Inc.
Orthopedic · 158d
Cleared Oct 18, 2017
Stryker Spine Navigation System with SpineMap 3D software application,...
K172034 · OLO
Stryker Corporation
Orthopedic · 105d
Cleared Sep 21, 2017
Mako Total Knee Application
K172219 · OLO
Mako Surgical Corp.
Orthopedic · 59d
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