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
241–264 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Dec 23, 2020
CIRQ Robotic Alignment Module, Cirq, Cirq Robotic Alignment Module Spinal,...
K202320 · OLO
Brainlab AG
Orthopedic · 128d
Cleared Dec 18, 2020
ADAPT for Gamma3
K202749 · OLO
Stryker GmbH
Orthopedic · 88d
Cleared Dec 10, 2020
Navbit Sprint System- Supine Registration, Navbit Sprint Kit - Lateral...
K200376 · OLO
Navbit Pty, Ltd.
Orthopedic · 296d
Cleared Dec 08, 2020
CD Horizon Spinal System Instruments
K203291 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 29d
Cleared Dec 02, 2020
NuVasive Navigation.S Instruments
K200719 · OLO
Nu Vasive, Incorporated
Orthopedic · 258d
Cleared Nov 13, 2020
TSolution One Total Knee Application
K203040 · OLO
THINK Surgical, Inc.
Orthopedic · 38d
Cleared Nov 09, 2020
iFuse Implant System - iFuse Navigation
K203110 · OLO
SI-BONE, Inc.
Orthopedic · 25d
Cleared Nov 02, 2020
Midas Rex Attachments and Dissecting Tools
K202552 · OLO
Medtronic Powered Surgical Solutions...
Orthopedic · 60d
Cleared Oct 27, 2020
Mazor X
K203005 · OLO
Mazor Robotics , Ltd.
Orthopedic · 26d
Cleared Sep 16, 2020
Symphony Navigation Ready Instruments and Universal Navigation Adaptor Set
K201661 · OLO
Medos International SARL
Orthopedic · 90d
Cleared Sep 10, 2020
Navigation Module of the Momentum System
K200845 · OLO
Ulrich Medical USA
Orthopedic · 163d
Cleared Sep 09, 2020
Perseus
K192653 · OLO
Orthokey Italia S.R.L.
Orthopedic · 351d
Cleared Sep 03, 2020
7D Surgical FlashLock 1, 7D Surgical Flex Rod Connector - 5.5 mm - 150 mm, 7D...
K201966 · OLO
7D Surgical, Inc.
Orthopedic · 50d
Cleared Sep 02, 2020
ExactechGPS System
K193618 · OLO
Blue Ortho
Orthopedic · 251d
Cleared Aug 07, 2020
K2M Navigation Instruments
K201006 · OLO
K2m, Inc.
Orthopedic · 112d
Cleared Aug 05, 2020
CarboClear Navigated Instruments
K201251 · OLO
CarboFix Orthopedics , Ltd.
Orthopedic · 86d
Cleared Jul 31, 2020
Navigation Enabled Intruments
K200791 · OLO
Medos International SARL
Orthopedic · 127d
Cleared Jul 30, 2020
Joimax Intracs System
K192663 · OLO
Joimax GmbH
Orthopedic · 309d
Cleared Jul 14, 2020
Mako Total Knee Application
K193515 · OLO
Mako Surgical Corp.
Orthopedic · 208d
Cleared Jul 10, 2020
ExcelsiusGPS Cranial 1.0 Module
K200047 · OLO
Globus Medical, Inc.
Neurology · 183d
Cleared Jun 27, 2020
OMNIBotics Knee System
K200888 · OLO
Corin, Ltd.
Orthopedic · 85d
Cleared Jun 26, 2020
Streamline Navigated Instruments
K200095 · OLO
Pioneer Surgical Technology, Inc....
Orthopedic · 162d
Cleared Jun 18, 2020
Harvey(R) Surgical Assistant
K200892 · OLO
Orthalign, Inc.
Orthopedic · 76d
Cleared Jun 18, 2020
NavLock Trackers
K201327 · OLO
Medtronic Navigation
Orthopedic · 30d