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
193–216 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared May 02, 2022
ExactechGPS® System
K213877 · OLO
Blue Ortho
Orthopedic · 140d
Cleared Apr 29, 2022
Camber Spine Navigation System
K220038 · OLO
Camber Spine Technologies
Orthopedic · 114d
Cleared Apr 22, 2022
ROSA® Knee System
K213708 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 149d
Cleared Apr 15, 2022
Mako Total Knee Application
K220459 · OLO
Mako Surgical Corp.
Orthopedic · 57d
Cleared Apr 13, 2022
Spine and Trauma Navigation System, Spine & Trauma 3D Navigation, Instrument...
K212245 · OLO
Brainlab AG
Orthopedic · 268d
Cleared Mar 31, 2022
NEXXT SPINE NAVIGATION System
K220291 · OLO
Nexxt Spine, LLC
Orthopedic · 58d
Cleared Mar 29, 2022
REAL INTELLIGENCE CORI
K220255 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 57d
Cleared Feb 09, 2022
DeGen Navigated Instrumentation
K213918 · OLO
Degen Medical
Orthopedic · 56d
Cleared Feb 09, 2022
Catalyft™ PL Expandable Interbody System Navigated Instruments, Anteralign™...
K214011 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 49d
Cleared Jan 19, 2022
CoreLink Navigation Instruments
K214059 · OLO
Corelink, LLC
Orthopedic · 23d
Cleared Jan 14, 2022
iASSIST Knee System
K213033 · OLO
Orthosoft D/B/A Zimmer Cas
Orthopedic · 115d
Cleared Jan 11, 2022
360CAS
K213380 · OLO
Kico Knee Innovation Company Pty Limited
Orthopedic · 90d
Cleared Jan 07, 2022
Vital Navigation System
K213720 · OLO
Zimvie (Zimmer Biomet Spine, Inc.)
Orthopedic · 44d
Cleared Jan 06, 2022
ExactechGPS Total Shoulder Application, Equinoxe Planning Software
K213546 · OLO
Blue Ortho
Orthopedic · 59d
Cleared Dec 23, 2021
Integrity Implants Navigated Instruments
K212088 · OLO
Integrity Implants, Inc.
Orthopedic · 170d
Cleared Nov 03, 2021
REAL INTELLIGENCE CORI (CORI)
K212537 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 83d
Cleared Oct 13, 2021
CoreLink Navigation Instruments
K212825 · OLO
Corelink, LLC
Orthopedic · 40d
Cleared Sep 27, 2021
Dark Star Navigation Instrument System
K212028 · OLO
Republic Spine, LLC
Orthopedic · 90d
Cleared Aug 27, 2021
Virage Navigation System
K212023 · OLO
Zimmer Biomet Spine, Inc.
Orthopedic · 59d
Cleared Aug 25, 2021
ExcelsiusHub
K211616 · OLO
Globus Medical, Inc.
Orthopedic · 91d
Cleared Aug 19, 2021
GX Navigation Instrument System
K202836 · OLO
Life Spine, Inc.
Orthopedic · 328d
Cleared Aug 12, 2021
VERTICALE Navigation Instruments
K212007 · OLO
Silony Medical GmbH
Orthopedic · 45d
Cleared Jul 29, 2021
NuVasive Pulse System
K210574 · OLO
Nu Vasive, Incorporated
Orthopedic · 153d
Cleared Jul 14, 2021
ARVIS Surgical Navigation System
K203115 · OLO
Insight Medical Systems, Inc.
Orthopedic · 271d