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
265–288 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
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
Cleared Apr 10, 2020
OrthAlign Plus System
K200642 · OLO
Orthalign, Inc.
Orthopedic · 30d
Cleared Feb 14, 2020
Real Intelligence Cori
K193120 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 94d
Cleared Feb 02, 2020
Mako Total Hip Application
K193128 · OLO
Mako Surgical Corp.
Orthopedic · 82d
Cleared Jan 17, 2020
Black Diamond Navigation Instruments
K192495 · OLO
Osseus Fusion Systems
Orthopedic · 128d
Cleared Dec 19, 2019
Spinal Elements Navigated Instruments
K190881 · OLO
Spinal Elements, Inc.
Orthopedic · 259d
Cleared Dec 13, 2019
Corelink Navigation Instruments
K182731 · OLO
Corelink, LLC
Orthopedic · 441d
Cleared Dec 11, 2019
TSolution One Total Knee Application
K193135 · OLO
THINK Surgical, Inc.
Orthopedic · 29d
Cleared Dec 02, 2019
Vital Navigation System
K191722 · OLO
Zimmer Biomet Spine, Inc.
Orthopedic · 158d
Cleared Nov 22, 2019
Navigated Anterolateral Disc Prep Instruments
K192336 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 86d
Cleared Nov 14, 2019
Brainlab Compatible K2M Navigation Instruments
K192911 · OLO
K2m, Inc.
Orthopedic · 30d
Cleared Nov 05, 2019
iASSIST Knee System
K192080 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 95d
Cleared Nov 05, 2019
7D Surgical System
K192140 · OLO
7D Surgical, Inc.
Orthopedic · 89d
Cleared Oct 29, 2019
Zimmer Biomet Universal Navigation System
K192133 · OLO
Zimmer Biomet Spine, Inc.
Orthopedic · 83d
Cleared Oct 29, 2019
ROSA ONE Spine application
K192173 · OLO
Medtech S.A
Orthopedic · 78d
Cleared Oct 24, 2019
Zimmer Biomet Universal Navigation System
K190556 · OLO
Zimmer Biomet Spine, Inc.
Orthopedic · 233d
Cleared Oct 18, 2019
SYMPHONY Navigation Ready Instruments, Universal Navigation Adaptor Set
K191943 · OLO
Medos International SARL
Orthopedic · 88d
Cleared Oct 10, 2019
Spine Wave Navigated Instruments
K192526 · OLO
Spine Wave, Inc.
Orthopedic · 27d
Cleared CT Oct 08, 2019
TSolution One Total Knee Application
K191369 · OLO
THINK Surgical, Inc.
Orthopedic · 139d