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
313–336 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Nov 02, 2018
CD HORIZON Spinal System Instruments for use with MAZOR X Stealth Edition
K182121 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 88d
Cleared Oct 24, 2018
Spine Wave Navigated Instruments
K181596 · OLO
Spine Wave, Inc.
Orthopedic · 128d
Cleared Oct 12, 2018
ADAPT for Gamma3, Gamma3
K181848 · OLO
Stryker GmbH
Orthopedic · 93d
Cleared Sep 21, 2018
Spineology Navigation Instruments
K182345 · OLO
Spineology, Inc.
Orthopedic · 24d
Cleared Sep 19, 2018
Ortoma Treatment Solution - OTS
K181449 · OLO
Ortoma AB
Orthopedic · 110d
Cleared Jul 11, 2018
Ziehm RFD 3D Tracker
K180816 · OLO
Medtronic Navigation
Orthopedic · 104d
Cleared Jun 29, 2018
NuVasive Pulse System
K180038 · OLO
Nu Vasive, Incorporated
Orthopedic · 175d
Cleared Jun 25, 2018
Navigation Instruments
K180690 · OLO
Globus Medical, Inc.
Orthopedic · 101d
Cleared May 17, 2018
Navigated INFINITY Instruments
K181111 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 20d
Cleared May 11, 2018
SeaSpine Navigation System
K172517 · OLO
SeaSpine Orthopedics Corporation
Orthopedic · 263d
Cleared May 02, 2018
ADAPT for Gamma3
K173946 · OLO
Stryker GmbH
Orthopedic · 126d
Cleared May 02, 2018
7D Surgical System
K180352 · OLO
7D Surgical, Inc.
Orthopedic · 83d
Cleared May 02, 2018
Spineology Navigation Instruments
K180796 · OLO
Spineology, Inc.
Orthopedic · 36d
Cleared Apr 30, 2018
Mazor X
K180307 · OLO
Mazor Robotics , Ltd.
Orthopedic · 87d
Cleared Apr 27, 2018
OLYMPIC Navigated Instruments
K172166 · OLO
Astura Medical
Orthopedic · 283d
Cleared Apr 24, 2018
Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
K180277 · OLO
Smith & Nephew, Inc.
Orthopedic · 83d
Cleared Apr 06, 2018
NAVIO™ Surgical System (NAVIO system)
K180271 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 65d
Cleared Mar 08, 2018
Navigated Instrument System
K172115 · OLO
Orthofix, Inc.
Orthopedic · 238d
Cleared Jan 18, 2018
Navigated INFINITY™ Instruments
K173338 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 87d
Cleared Jan 16, 2018
K2M Navigation Instruments
K171556 · OLO
K2m
Orthopedic · 231d
Cleared Jan 05, 2018
Spineology Navigation Instruments
K172518 · OLO
Spineology, Inc.
Orthopedic · 137d
Cleared Dec 21, 2017
NuVasive Navigation Instruments
K172623 · OLO
Nu Vasive, Incorporated
Orthopedic · 111d
Cleared Nov 24, 2017
ExactechGPS Total Shoulder Application
K173372 · OLO
Blue Ortho
Orthopedic · 28d
Cleared Nov 22, 2017
OrthAlign Plus System
K172462 · OLO
Orthalign, Inc.
Orthopedic · 100d