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
49–72 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
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
Cleared Apr 02, 2025
FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments
K243659 · OLO
SeaSpine Orthopedics Corporation
Orthopedic · 126d
Cleared Mar 24, 2025
Innovasis Navigation Instruments
K250182 · OLO
Innovasis, Inc.
Orthopedic · 61d
Cleared Mar 21, 2025
Consolidated Operating Room Equipment (CORE) 2 Console
K243958 · OLO
Stryker Instruments
Orthopedic · 88d
Cleared Mar 14, 2025
mBôs (Monogram mBôs TKA System)
K242121 · OLO
Monogram Orthopaedics, Inc.
Orthopedic · 238d
Cleared Mar 07, 2025
SPINEART Navigation Instrument System
K242890 · OLO
Spineart SA
Orthopedic · 165d
Cleared Mar 07, 2025
Op.n(TM) Navigation
K242914 · OLO
Ecential Robotics
Orthopedic · 164d