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
217–240 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Jul 08, 2021
StealthStation Spinous Process Clamps
K211442 · OLO
Medtronic Navigation
Orthopedic · 59d
Cleared Jun 23, 2021
CD Horizon Spinal System
K211596 · OLO
Medtronic
Orthopedic · 30d
Cleared Jun 21, 2021
7D Registration Frame, 7D Flex Iliac Pin Connector, 7D Pin Guide Block, 7D...
K210457 · OLO
7D Surgical, Inc.
Orthopedic · 125d
Cleared Jun 09, 2021
Navigated Anterolateral Disc Prep Instruments
K211441 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 19, 2021
CUVIS-spine
K201569 · OLO
Curexo, Inc.
Orthopedic · 342d
Cleared Apr 19, 2021
ROSA Partial Knee System
K210121 · OLO
Orthosoft D/B/A Zimmer Cas
Orthopedic · 90d
Cleared Apr 12, 2021
OMNIVision system
K203751 · OLO
Corin USA
Orthopedic · 110d
Cleared Apr 02, 2021
DeGen Navigated Instrumentation
K203816 · OLO
Degen Medical
Orthopedic · 94d
Cleared Apr 01, 2021
TSolution One Total Knee Application
K210668 · OLO
THINK Surgical, Inc.
Orthopedic · 27d
Cleared Mar 23, 2021
Navigated Spine Instruments
K203205 · OLO
Stryker Spine
Orthopedic · 144d
Cleared Mar 23, 2021
7D Surgical System - Drill Guide
K210555 · OLO
7D Surgical, Inc.
Orthopedic · 26d
Cleared Mar 19, 2021
SPINEART Navigation Instrument System
K210472 · OLO
Spineart
Orthopedic · 30d
Cleared Mar 18, 2021
Automatic Registration
K203679 · OLO
Brainlab AG
Orthopedic · 91d
Cleared Feb 26, 2021
Erisma LP Navigated Instruments
K202956 · OLO
Clariance, Sas
Orthopedic · 149d
Cleared Feb 24, 2021
Practical Navigation Surgical Guidance System (PNSGS)
K202184 · OLO
Practical Navigation, LLC
Orthopedic · 204d
Cleared Feb 04, 2021
RESPONSE Navigation Instruments
K203573 · OLO
OrthoPediatrics Corp.
Orthopedic · 59d
Cleared Jan 14, 2021
VELYS™ Robotic-Assisted Solution
K202769 · OLO
Depuy Ireland UC
Orthopedic · 115d
Cleared Jan 04, 2021
ChoiceSpine Navigation System
K203561 · OLO
Choice Spine, LLC
Orthopedic · 28d
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