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
241–264 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
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
Cleared Jun 12, 2020
REAL INTELLIGENCE CORI (CORI)
K201022 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 53d
Cleared Jun 10, 2020
Naviswiss Hip Navigation System
K193094 · OLO
Naviswiss AG
Orthopedic · 216d
Cleared Jun 10, 2020
TSolution® One Total Knee Application
K201255 · OLO
THINK Surgical, Inc.
Orthopedic · 30d
Cleared Jun 02, 2020
HIP7
K193307 · OLO
Brainlab AG
Orthopedic · 186d
Cleared May 29, 2020
Stealthstation S8 Spine Software v1.3.0
K201189 · OLO
Medtronic Navigation, Inc.
Orthopedic · 28d
Cleared May 08, 2020
Mazor X
K200935 · OLO
Mazor Robotics , Ltd.
Orthopedic · 30d