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.

175,450 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
174,955 results
91393–91416 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 1997
SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II
K973586 · HWC
Spinal Concepts, Inc.
Orthopedic · 46d
Cleared Nov 07, 1997
D.O.R.C. SOLUX LIGHT SOURCE
K973757 · MPA
Dutch Ophthalmic USA, Inc.
Ophthalmic · 36d
Cleared Nov 06, 1997
LIFEPAK 300
K962359 · MKJ
Physio-Control Corp.
Cardiovascular · 505d
Cleared Nov 06, 1997
(VCOM, IRVS, RVS) CENTRAL MONITORING STATION, V-LINK OR AMBULATORY...
K962473 · MSX
Data Critical Corporation
Cardiovascular · 499d
Cleared Nov 06, 1997
MONOCLONAL MOUSE ANTI-HUMAN CD30, KI-1 ANTIGEN, BER-H2 ANTIBODY FOR...
K965022 · DEH
Dako Corp.
Immunology · 325d
Cleared Nov 06, 1997
QUEST VESSEL CATHETER
K971928 · DWF
Quest Medical, Inc.
Cardiovascular · 163d
Cleared Nov 06, 1997
BABYBIRD VENTILATOR, PORTABLE LIFECARE VENTILATOR, EXTERNAL PRESSURE LIMITER,...
K972203 · CBK
Allied Healthcare Products, Inc.
Anesthesiology · 148d
Cleared Nov 06, 1997
POLY (VINYL) EXAM GLOVE, POWDER-FREE
K972624 · LYZ
Copioumed Intl., Inc.
General Hospital · 115d
Cleared Nov 06, 1997
ENDOSCOPES W/PERMANENT AND REMOVABLE EYEPIECE, PANOVIEW PLUS TELESCOPE...
K972927 · GCJ
Richard Wolf Medical Instruments Corp.
General & Plastic Surgery · 90d
Cleared Nov 06, 1997
3M CDI BLOOD PARAMETER MONITORING SYSTEM 500
K972962 · DRY
3M Company
Cardiovascular · 87d
Cleared Nov 06, 1997
DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER
K973007 · DYB
Datascope Corp.
Cardiovascular · 85d
Cleared Nov 06, 1997
CONVEEN EASICATH SET
K973070 · EZD
Coloplast Corp.
Gastroenterology & Urology · 80d
Cleared Nov 06, 1997
OMNI F.T. LATEX EXAMINATION GLOVE, POWDERED
K973134 · LYY
Omnigrace , Ltd.
General Hospital · 77d
Cleared Nov 06, 1997
CARIES STAIN
K973200 · LFC
Parkell, Inc.
Dental · 72d
Cleared Nov 06, 1997
STEREOTACTIC NEEDLE CORE BIOPSY SYSTEM
K973215 · KNW
Laurus Medical Corp.
Gastroenterology & Urology · 71d
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