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
433–445 of 445
Search insights Median review: 95d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
Cleared Feb 23, 2010
SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0
K100107 · OLO
Smith & Nephew, Inc.
Orthopedic · 40d
Cleared Jan 21, 2010
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK
K090953 · OLO
Praxim Medivision, SA
Orthopedic · 293d
Cleared Sep 28, 2009
ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-HIP
K091998 · OLO
Mako Surgical Corp.
Orthopedic · 88d
Cleared Sep 25, 2009
KNEEALIGN SYSTEM
K091411 · OLO
Orthalign, Inc.
Orthopedic · 135d
Cleared Sep 11, 2009
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM, VERSION 1.1
K092497 · OLO
Smith & Nephew, Inc.
Orthopedic · 28d
Cleared Jun 23, 2009
ORTHOPILOT NEXT GENERATION-UKA SOFTWARE, MODEL FS210
K090375 · OLO
Aesculap Implant System, Inc.
Orthopedic · 126d
Cleared Jun 19, 2009
MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP
K083644 · OLO
Mako Surgical Corp.
Orthopedic · 192d
Cleared May 27, 2009
SMITH & NEPHEW PIGALILEO SCREW TARGETING SYSTEM V 1.0
K090420 · OLO
Smith & Nephew, Inc.
Orthopedic · 98d
Cleared Apr 08, 2009
BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED
K083483 · OLO
Brainlab AG
Orthopedic · 135d
Cleared Apr 01, 2009
SPINE & TRAUMA ICT
K083310 · OLO
Brainlab AG
Orthopedic · 142d
Cleared Mar 11, 2009
PIGALILEO TKR BASE V2.3 AND CAS V4.1
K090313 · OLO
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Feb 19, 2009
ORTHO-MAP-ONCOLOGY NAVIGATION SOFTWARE, MODELS 6005-650-000, 6005-651-000
K083009 · OLO
Stryker Leibinger GmbH & Co KG
Orthopedic · 133d
Cleared Jan 15, 2009
IMNS MEDACTA NAVIGATION SYSTEM
K083872 · OLO
Medacta International S.A.
Orthopedic · 17d