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
169–192 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Dec 09, 2022
SeaSpine 7D Navigation Instruments
K222753 · OLO
SeaSpine Orthopedics Corporation
Orthopedic · 88d
Cleared Oct 28, 2022
Remi Robotic Navigation System
K223070 · OLO
Fusion Robotics, LLC
Orthopedic · 28d
Cleared Oct 27, 2022
Cirq Arm System (2.0)
K222966 · OLO
Brainlab AG
Orthopedic · 30d
Cleared Oct 07, 2022
CUVIS-spine
K222698 · OLO
Curexo, Inc.
Orthopedic · 30d
Cleared Oct 04, 2022
ROSA® Knee System
K221928 · OLO
Orthosoft D/B/A Zimmer Cas
Orthopedic · 95d
Cleared Sep 29, 2022
Anteralign™ LS Spinal System with Titan nanoLOCK™ Surface Technology MAZORX...
K222383 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 55d
Cleared Aug 30, 2022
Spine & Trauma Navigation, Spine Navigation, Navigation Software Spine &...
K221618 · OLO
Brainlab AG
Orthopedic · 88d
Cleared Aug 19, 2022
REAL INTELLIGENCE CORI
K221224 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 113d
Cleared Aug 09, 2022
“POINT” Kinguide Robotic-Assisted Surgical System
K220241 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 193d
Cleared Aug 05, 2022
Spineology Navigation Instruments
K213876 · OLO
Spineology, Inc.
Orthopedic · 235d
Cleared Jul 27, 2022
Real Intelligence Cori
K220958 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 117d
Cleared Jul 14, 2022
Anatase Spine Surgery Navigation System, Model number: SNS-Spine2-S and...
K220348 · OLO
Remex Medical Corporation
Orthopedic · 157d
Cleared Jul 14, 2022
E-GPS Navigated Instruments
K220862 · OLO
Precision Spine, Inc.
Orthopedic · 112d
Cleared Jul 07, 2022
SkyWalker Total Knee System
K213873 · OLO
Microport Navibot International, LLC
Orthopedic · 206d
Cleared Jul 06, 2022
ChoiceSpine Navigation System
K220024 · OLO
Choice Spine, LLC
Orthopedic · 182d
Cleared Jul 06, 2022
SURGIVISIO Device
K221028 · OLO
Ecential Robotics
Orthopedic · 90d
Cleared Jun 03, 2022
Knee 3
K220652 · OLO
Brainlab AG
Orthopedic · 88d
Cleared Jun 01, 2022
CoreLink Navigation Instruments
K220973 · OLO
Corelink, LLC
Orthopedic · 58d
Cleared May 27, 2022
VisAR
K220146 · OLO
Novarad Corporation
Orthopedic · 128d
Cleared May 27, 2022
Spine Guidance Software, Stryker Q Guidance System
K220593 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 87d
Cleared May 25, 2022
Anteralign(TM) Spinal System with Titan NanoLOCK Surface Technology Navigated...
K221180 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 20, 2022
7D Surgical System - Percutaneous Application (7D Flash Frame)
K220522 · OLO
7D Surgical
Orthopedic · 86d
Cleared May 12, 2022
Universal Pilot Guidance Instrument System
K213491 · OLO
Ctl Medical Corporation
Orthopedic · 192d
Cleared May 05, 2022
Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set
K212756 · OLO
Medos International SARL
Orthopedic · 247d