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
433–439 of 439
Search insights Median review: 97d Cleared: 100% Top manufacturer: Brainlab AG Lead specialty: Orthopedic
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