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
217–240 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
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
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