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
145–168 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Jul 20, 2023
ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation...
K223301 · OLO
Spinecraft, LLC
Orthopedic · 266d
Cleared Jul 18, 2023
Robotic Graft Delivery Instruments
K230716 · OLO
Medtronic Sofamor Danek, Inc.
Orthopedic · 125d
Cleared Jul 17, 2023
“POINT” Kinguide Agile Hybrid Navigation System
K230087 · OLO
Point Robotics MedTech, Inc.
Orthopedic · 186d
Cleared Jul 12, 2023
Zavation Navigation Instrument System
K223808 · OLO
Zavation Medical Products, LLC
Orthopedic · 204d
Cleared Jun 27, 2023
VADER® Pedicle System Navigated Instruments
K230861 · OLO
Icotec AG
Orthopedic · 90d
Cleared Jun 27, 2023
RI.KNEE Adjustable Tibia Cut Guide
K230876 · OLO
Enztec Limited
Orthopedic · 89d
Cleared Jun 23, 2023
EUROPA™ Navigated Instruments
K230369 · OLO
MiRus, LLC
Orthopedic · 133d
Cleared Jun 22, 2023
CUVIS-spine
K223558 · OLO
Curexo, Inc.
Orthopedic · 206d
Cleared May 26, 2023
CD Horizon™ Spinal System
K231184 · OLO
Medtronic Sofamor Danek USA, Inc.
Orthopedic · 30d
Cleared May 25, 2023
S-COMP Reform® POCT Navigation Instruments
K231229 · OLO
Precision Spine, Inc.
Orthopedic · 27d
Cleared May 05, 2023
Rod Registration Frame
K230989 · OLO
Nu Vasive, Incorporated
Orthopedic · 29d
Cleared May 02, 2023
Excella Navigation Instruments
K223511 · OLO
Innovasis, Inc.
Orthopedic · 161d
Cleared May 02, 2023
CoreLink Navigation Instruments
K230880 · OLO
Corelink, LLC
Orthopedic · 33d
Cleared Apr 25, 2023
TMINI™ Miniature Robotic System
K230202 · OLO
THINK Surgical, Inc.
Orthopedic · 90d
Cleared Apr 21, 2023
Paradigm System
K222291 · OLO
Proprio, Inc.
Orthopedic · 263d
Cleared Apr 21, 2023
Anatase Spine Surgery Navigation System
K230783 · OLO
Remex Medical Corp.
Orthopedic · 30d
Cleared Apr 07, 2023
Mazor X System (Mazor X Stealth Edition)
K230064 · OLO
Mazor Robotics , Ltd.
Orthopedic · 88d
Cleared Mar 29, 2023
ROSA® Knee System
K230243 · OLO
Orthosoft D/B/A Zimmer Cas
Orthopedic · 58d
Cleared Mar 23, 2023
ATEC Lateral Navigation Instruments
K223765 · OLO
Alphatec Spine, Inc.
Orthopedic · 98d
Cleared Mar 13, 2023
Remi Robotic Navigation System
K223350 · OLO
Fusion Robotics, LLC
Orthopedic · 131d
Cleared Mar 08, 2023
PathKeeper System
K222355 · OLO
Pathkeeper Surgical , Ltd.
Orthopedic · 216d
Cleared Feb 22, 2023
Rosa Knee System
K230180 · OLO
Orthosoft Inc. (d/b/a) Zimmer CAS
Orthopedic · 30d
Cleared Feb 13, 2023
Ortho Guidance Precision Knee Software, Ortho Guidance Express Knee Software,...
K223767 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 60d
Cleared Jan 31, 2023
Naviswiss Knee
K223351 · OLO
Naviswiss AG
Orthopedic · 90d