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
49–72 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Nov 05, 2025
ExcelsiusGPS™ Instruments
K250599 · OLO
Globus Medical, Inc.
Orthopedic · 250d
Cleared Oct 31, 2025
Firebird SI Navigation System
K252088 · OLO
Orthofix US, LLC
Orthopedic · 121d
Cleared Oct 28, 2025
Navigated Instruments
K252742 · OLO
Tyber Medical, LLC
Orthopedic · 61d
Cleared Oct 27, 2025
OsteoCentric Navigated Instruments System
K250520 · OLO
Osteocentric Technologies, Inc.
Orthopedic · 248d
Cleared Oct 17, 2025
StealthStation S8 Spine Software
K251282 · OLO
Medtronic Navigation, Inc.
Orthopedic · 176d
Cleared Oct 10, 2025
TMINI Miniature Robotic System
K252544 · OLO
THINK Surgical, Inc.
Orthopedic · 59d
Cleared Sep 25, 2025
RPS Primary TKA Software
K251971 · OLO
Stryker Instruments
Orthopedic · 91d
Cleared Sep 15, 2025
iGPS Navigation Instruments
K251780 · OLO
SI-BONE, Inc.
Orthopedic · 97d
Cleared Sep 12, 2025
Spine & Trauma Navigation Instruments
K252562 · OLO
Brainlab AG
Orthopedic · 29d
Cleared Sep 11, 2025
Mazor X System / Mazor X Stealth Edition
K251316 · OLO
Mazor Robotics , Ltd.
Orthopedic · 135d
Cleared Aug 18, 2025
Evolution Spine Navigation Instruments
K250167 · OLO
Evolution Spine
Orthopedic · 209d
Cleared Jul 30, 2025
CORUS™ Navigation System-GX
K251060 · OLO
Providence Medical Technology, Inc.
Orthopedic · 117d
Cleared Jul 23, 2025
Innovasis Navigation Instruments (Vector G-E Navigation Instruments and the...
K251073 · OLO
Innovasis, Inc.
Orthopedic · 106d
Cleared Jun 20, 2025
TMINI Miniature Robotic System
K250877 · OLO
THINK Surgical, Inc.
Orthopedic · 88d
Cleared Jun 18, 2025
SPINEART Navigation Instrument System
K242933 · OLO
Spineart SA
Orthopedic · 266d
Cleared Jun 05, 2025
Stealth™ Spine Clamps
K242464 · OLO
Medtronic Navigation, Inc.
Orthopedic · 290d
Cleared Jun 04, 2025
Paradigm System
K250879 · OLO
Proprio, Inc.
Orthopedic · 72d
Cleared May 29, 2025
Anatase Spine Surgery Navigation System and Remex Spine Surgery Navigation...
K251315 · OLO
Remex Medical Corp.
Orthopedic · 30d
Cleared May 16, 2025
OTS Hip
K250086 · OLO
Ortoma AB
Orthopedic · 123d
Cleared May 08, 2025
Altus Spine Navigation System
K243419 · OLO
Altus Partners, LLC
Orthopedic · 185d
Cleared Apr 25, 2025
Mako Total Knee Application (3.0)
K250608 · OLO
Mako Surgical Corp.
Orthopedic · 56d
Cleared Apr 23, 2025
Dynamis Robotic Surgical System
K243326 · OLO
LEM Surgical AG
Orthopedic · 181d
Cleared Apr 16, 2025
Medyssey Navigation System
K242806 · OLO
Medyssey Co, Ltd.
Orthopedic · 211d
Cleared Apr 03, 2025
Salvo® Robotic Navigation Instruments
K243514 · OLO
Spine Wave, Inc.
Orthopedic · 141d