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.

175,218 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,724 results
68737–68760 of 174,724
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 17, 2004
MODIFICATION TO GIVEN DIAGNOSTIC SYSTEM
K040248 · NEZ
Given Imaging , Ltd.
Gastroenterology & Urology · 14d
Cleared Feb 13, 2004
INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION
K031745 · BZD
Sensor Medics Corp.
Anesthesiology · 253d
Cleared Feb 13, 2004
ECHO SOUNDER EX-101EX 8 MHZ
K031931 · DPW
Koven Technology, Inc.
Cardiovascular · 235d
Cleared Feb 13, 2004
MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
K032619 · HCG
Surgica Corp.
Neurology · 171d
Cleared Feb 13, 2004
THE ULTRA SYSTEM SP
K032813 · KCT
Promedica, Inc.
General Hospital · 157d
Cleared Feb 13, 2004
NOVOSCI READY SYSTEM, MODEL RS-200
K033270 · KFM
Novosci Corp.
Cardiovascular · 126d
Cleared Feb 13, 2004
WFSI'S REPROCESSED COMPRESSION SLEEVE DEVICES
K033615 · JOW
Wheaton Franciscan Services Inc.,...
Cardiovascular · 88d
Cleared Feb 13, 2004
PICOSAT II SP02 PULSE OXIMETRY MODULE AND M3001A MULTI-MEASUREMENT SERVER
K033715 · DQA
Philips Medical Systems, Inc.
Anesthesiology · 79d
Cleared Feb 13, 2004
VASCULAR SOLUTIONS AUTO-FILL SYRINGE KIT
K033721 · FMF
Vascular Solutions, Inc.
General Hospital · 79d
Cleared Feb 13, 2004
EIUS UNICOMPARTMENTAL KNEE SYSTEM
K033769 · HSX
Howmedica Osteonics Corp.
Orthopedic · 72d
Cleared Feb 13, 2004
BAYER SPECIFIC PROTEIN REFERENCE SERUM
K033791 · JIX
Bayer Healthcare, LLC
Chemistry · 71d
Cleared Feb 13, 2004
TITANIUM TOGGLE BUTTON(S)
K033838 · MBI
Biomet Manufacturing, Inc.
Orthopedic · 65d
Cleared Feb 13, 2004
ELECSYS C-PEPTIDE CALSET
K033873 · JIX
Roche Diagnostics Corp.
Toxicology · 60d
Cleared Feb 13, 2004
OPTETRAK TOTAL KNEE SYSTEM, HI-FLEX ASYMMETRIC POSTERIOR-STABILIZED CEMENTED...
K033883 · JWH
Exactech, Inc.
Orthopedic · 60d
Cleared Feb 13, 2004
HEMOSIL FACTOR VIII DEFICIENT PLASMA
K034007 · GJT
Instrumentation Laboratory CO
Hematology · 51d
Cleared Feb 13, 2004
MARATHON FLOW DIRECTED MICRO CATHETER, MODEL 105-5055
K034036 · KRA
Micro Therapeutics, Inc.
Cardiovascular · 46d
Cleared Feb 13, 2004
PERCUTANEOUS DILATION TRACHEOSTOMY KIT WITH SINGLE STAGE DILATOR AND SOFT...
K040014 · JOH
Portex , Ltd.
Anesthesiology · 51d
Cleared Feb 13, 2004
LEVIA PHOTOTHERAPY SYSTEM
K040062 · FTC
Lerner Medical Devices, Inc.
General & Plastic Surgery · 31d
Cleared Feb 13, 2004
CANNON II PLUS
K040078 · MSD
Arrow International, Inc.
Gastroenterology & Urology · 30d
Cleared Feb 13, 2004
MEDLINE STRIDER MIDI 3
K040097 · INI
Medline Industries, Inc.
Physical Medicine · 24d
Cleared Feb 13, 2004
VICEROY INFLATION DEVICE
K040138 · MAV
Merit Medical Systems, Inc.
Cardiovascular · 22d
Cleared Feb 13, 2004
BARD ATLAS PTA BALLOON DILATATION CATHETER
K040243 · DQY
C.R. Bard, Inc.
Cardiovascular · 10d
Cleared Feb 12, 2004
TITANIUM MESH SYSTEM
K032371 · MQP
Encore Medical, L.P.
Orthopedic · 195d
Cleared Feb 12, 2004
MEDLINE STRIDER, MODELS MIDI 3 AND MIDI 4
K032446 · INI
Medline Industries, Inc.
Physical Medicine · 188d