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
1–24 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Jul 30, 2026
Navbit MARQ (PRD-001-SUP (Supine Registration Kit), PRD-001-LAT (Lateral...
K261410 · OLO
Suite 201, National Innovation Centre
Orthopedic · 91d
Cleared Jul 29, 2026
SPINEART Navigation Instrument System
K261205 · OLO
Spineart SA
Orthopedic · 107d
Cleared Jul 24, 2026
TMINI Miniature Robotic System
K261024 · OLO
THINK Surgical, Inc.
Orthopedic · 116d
Cleared Jul 24, 2026
Ion-L Navigated Instruments
K262121 · OLO
SurGenTec, LLC
Orthopedic · 31d
Cleared Jul 22, 2026
Op.n™ Spine Navigation and Robotic Guidance
K261113 · OLO
Ecential Robotics
Orthopedic · 110d
Cleared Jul 01, 2026
OTS Hip
K261852 · OLO
Ortoma AB
Orthopedic · 28d
Cleared Jun 26, 2026
VERTICALE® Navigation Instruments
K253921 · OLO
Silony Medical GmbH
Orthopedic · 200d
Cleared Jun 25, 2026
VELYS™ Robotic-Assisted Solution
K260480 · OLO
Depuy Ireland UC
Orthopedic · 132d
Cleared Jun 20, 2026
Dynamis Robotic Surgical System
K260369 · OLO
LEM Surgical AG
Orthopedic · 135d
Cleared Jun 18, 2026
CORUS™ Navigation System-GN
K261665 · OLO
Providence Medical Technology, Inc.
Orthopedic · 29d
Cleared Jun 02, 2026
SIMPACT Sacroiliac Joint Fixation System GX Navigation Instruments
K260571 · OLO
Life Spine, Inc.
Orthopedic · 103d
Cleared May 29, 2026
Navigated LLIF Impactable Tracker
K261060 · OLO
Tyber Medical, LLC
Orthopedic · 59d
Cleared May 26, 2026
CROSSNAV Navigation Enabled Instruments for Disc Preparation and Interbody
K254157 · OLO
Medos International SARL
Orthopedic · 155d
Cleared May 22, 2026
Ion-C Navigation Instruments
K260329 · OLO
SurGenTec, LLC
Orthopedic · 112d
Cleared May 21, 2026
ROSA® Shoulder System
K260582 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 90d
Cleared May 11, 2026
Pytheas Your Guided Trajectory
K252880 · OLO
Pytheas Navigation Sas
Orthopedic · 243d
Cleared Apr 16, 2026
Foundation Surgical Navigated Lateral Disc Prep Instruments
K260011 · OLO
Foundation Surgical Group, Inc.
Orthopedic · 104d
Cleared Apr 09, 2026
SPINEART Navigation Instrument System
K254158 · OLO
Spineart SA
Orthopedic · 108d
Cleared Mar 27, 2026
SYMPHONY Navigation Ready Instruments
K260240 · OLO
Medos International SARL
Orthopedic · 60d
Cleared Mar 26, 2026
REAL INTELLIGENCE™ CORI™
K260601 · OLO
Blue Belt Technologies, Inc.
Orthopedic · 30d
Cleared Mar 25, 2026
CUVIS-joint (CJ150)
K252037 · OLO
Curexo, Inc.
Orthopedic · 268d
Cleared Mar 20, 2026
TiLink-L Navigation Instruments
K253604 · OLO
SurGenTec, LLC
Orthopedic · 122d
Cleared Mar 18, 2026
EUROPA™ Posterior Cervical Fusion Navigated Instruments
K253444 · OLO
MiRus, LLC
Orthopedic · 167d
Cleared Mar 17, 2026
Q Pedicle Instruments
K260546 · OLO
K2m, Inc.
Orthopedic · 27d