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
91897–91920 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Nov 07, 1997
MICRO21 WITH WBC ESTIMATE
K973050 · JOY
Triangle Biomedical Sciences, Inc.
Hematology · 84d
Cleared Nov 07, 1997
PATIENT NITRILE EXAMINATION GLOVE (POWDERFREE)
K973058 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 81d
Cleared Nov 07, 1997
PATIENT NITRILE EXAMINATION GLOVE (LIGHTLY POWDERED)
K973059 · LZA
Sri Johani Sdn. Bhd.
General Hospital · 81d
Cleared Nov 07, 1997
KSEA INSTRUMENT SET FOR SAPHENOUS VEIN HARVESTING
K973068 · GCJ
Karl Storz Endoskop GmbH
General & Plastic Surgery · 81d
Cleared Nov 07, 1997
ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE
K973301 · MEG
Retractable Technologies, Inc.
General Hospital · 66d
Cleared Nov 07, 1997
UNCOATED ELECTROSURGICAL ELECTRODE
K973346 · GEI
Megadyne Medical Products, Inc.
General & Plastic Surgery · 63d
Cleared Nov 07, 1997
IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT
K973502 · LZK
Implantech Associates, Inc.
General & Plastic Surgery · 52d
Cleared Nov 07, 1997
KENDALL FAST-CATH PRE LUBRICATED URETHRAL CATHETER
K973546 · EZD
Kendall Healthcare Products Co....
Gastroenterology & Urology · 50d
Cleared Nov 07, 1997
DURALASTIC ANATOMICAL CHIN IMPLANTS
K973575 · FWP
Hanson Medical, Inc.
General & Plastic Surgery · 49d
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