FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
91921–91944 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 06, 1997
ACE PHENOBARBITAL REAGENT/AED CALIBRATORS
K973536 · DLJ
Schiapparelli Biosystems, Inc.
Chemistry · 49d
Cleared Nov 06, 1997
MEDI-PLUS, HEALTH-PLUS, SANITEX, RELIANCE
K973551 · LZA
Pwa Industries Sdn. Bhd.
General Hospital · 48d
Cleared Nov 06, 1997
INVOTEC EAR TAMPON (WICK) W/STRING
K973578 · KCN
Invotec International, Inc.
Ear, Nose, Throat · 48d
Cleared Nov 06, 1997
VITAPEX PRE-LOADED DENTAL SYRINGE
K973667 · KIF
Neodental Chemical Products Co., Ltd.
Dental · 42d
Cleared Nov 06, 1997
FINGERPRINT DRUG SCREENING DEVICE
K973726 · DKZ
Applied Technology Ventures, LLC
Toxicology · 37d
Cleared Nov 06, 1997
DADE TRU-LIQUID CARDIAC CONTROL
K973974 · JJT
Dade Intl., Inc.
Chemistry · 17d
Cleared Nov 05, 1997
ARGYLE AQUA-SEAL ALL PURPOSE AUTOTRANSFUSION CHEST DRAINAGE UNIT AND OPTIONAL...
K970857 · CAC
Davis & Geck, Inc.
Anesthesiology · 240d
Cleared Nov 05, 1997
AVE BRIDGE STENT SYSTEM
K971295 · FGE
Arterial Vascular Engineering, Inc.
Gastroenterology & Urology · 212d
Cleared Nov 05, 1997
MICRO ELECTRODES
K971838 · KNF
CooperSurgical, Inc.
Obstetrics & Gynecology · 170d
Cleared Nov 05, 1997
POWERTREK INSTRUMENTS
K972057 · ERL
Medtrek Corp.
Ear, Nose, Throat · 156d
Cleared Nov 05, 1997
POWDER-FREE HYPOALLERGENIC NITRILE EXAMINATION GLOVES
K972090 · LZA
Shen Wei (Usa), Inc.
General Hospital · 154d
Cleared Nov 05, 1997
SERAQUEST VZV IGG
K972295 · LFY
Quest Intl., Inc.
Microbiology · 139d
Cleared Nov 05, 1997
VITALMIX PLUS EMPTY I.V. CONTAINER
K972464 · KPE
Pacific Device, Inc.
General Hospital · 127d
Cleared Nov 05, 1997
MDC SAFE STEP SAFETY BLOOD COLLECTION NEEDLE SYSTEM
K973012 · FMI
MDC Research , Ltd.
General Hospital · 84d
Cleared Nov 05, 1997
L7 TRANSDUCER USED ON ASPEN MODEL ULTRASOUND SYSTEM
K973079 · ITX
Acuson Corp.
Radiology · 79d
Cleared Nov 05, 1997
DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)
K973081 · LLZ
Howtek, Inc.
Radiology · 79d
Cleared Nov 05, 1997
ORATEC INTERVENTIONS MODEL ORASTAT MONOPOLAR CAUTERY DEVICE
K973158 · GEI
Oratec Interventions, Inc.
General & Plastic Surgery · 75d
Cleared Nov 05, 1997
PASCO MIC AND MIC/ID PANELS
K973695 · JWY
Pasco Laboratories, Inc.
Microbiology · 40d
Cleared Nov 04, 1997
PARATREND 7 INTRAVASCULAR BLOOD GAS MONITORING SYSTEM
K953893 · CCC
Biomedical Sensors, Inc.
Anesthesiology · 810d
Cleared Nov 04, 1997
TRINITY DVT SYSTEM
K963957 · JOW
Delphi Consulting Group
Cardiovascular · 398d
Cleared Nov 04, 1997
AXSYM CA 125
K964020 · LTK
Abbott Laboratories
Immunology · 393d
Cleared Nov 04, 1997
IMX CA 125
K964185 · LTK
Abbott Diagnostics
Immunology · 379d
Cleared Nov 04, 1997
THERAPIK
K964397 · ILY
The Jenex Corporation
Physical Medicine · 365d
Cleared Nov 04, 1997
SMARTVAC SMOKE EVACUATION SYSTEM
K970352 · FYD
Isomedix Operations, Inc.
General Hospital · 278d