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
265–288 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
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 Oct 08, 2019
TSolution One Total Knee Application
K191369 · OLO
THINK Surgical, Inc.
Orthopedic · 139d
Cleared Oct 08, 2019
Premia Spine XL Instruments
K191854 · OLO
Premia Spine, Ltd.
Orthopedic · 90d
Cleared Oct 01, 2019
Intellijoint® Navigation System
K191507 · OLO
Intellijoint Surgical, Inc.
Orthopedic · 117d
Cleared Sep 27, 2019
Precision Spine Navigation Instrumentation
K181606 · OLO
Precision Spine, Inc.
Orthopedic · 465d
Cleared Sep 24, 2019
Mako Total Hip Application, Mako Total Knee Application
K191998 · OLO
Mako Surgical Corp.
Orthopedic · 60d
Cleared Sep 20, 2019
INTAI Surgery Navigation System
K180523 · OLO
Intai Technology Corporation
Orthopedic · 570d
Cleared Aug 29, 2019
Spine & Trauma Navigation
K183605 · OLO
Brainlab AG
Orthopedic · 246d