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
72577–72600 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jan 28, 2003
NON-DEHP, POWDER FREE VINYL EXAMINATION GLOVES
K024174 · LYZ
General Gloves Corp.
General Hospital · 41d
Cleared Jan 28, 2003
MONARCH SPINE SYSTEM
K024348 · MNH
Depuyacromed
Orthopedic · 29d
Cleared Jan 28, 2003
MODIFICATION TO ANIMEC, MODELS AM-2S-4, AM-2S-5, LT-1-4 & LT-1-5
K024373 · LGZ
Elltec Co., Ltd.
General Hospital · 28d
Cleared Jan 28, 2003
SOFT TISSUE ANCHORING WASHERS
K030031 · KGS
Accu-Speed, Incorporated
General & Plastic Surgery · 25d
Cleared Jan 28, 2003
VAXCEL WITH PASV PORT
K030083 · LJT
Boston Scientific Corp
General Hospital · 19d
Cleared Jan 28, 2003
LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY...
K030150 · JJY
Cliniqa Corporation
Chemistry · 13d
Cleared Jan 27, 2003
ACIST GENTOO CONTRAST INJECTION SYSTEM
K020892 · DXT
Acist Medical Systems
Cardiovascular · 314d
Cleared Jan 27, 2003
LID CHAIN EYELID WEIGHTS
K021750 · MML
Jedmed Instrument Co.
Ophthalmic · 244d
Cleared Jan 27, 2003
TERABYTE 2000 HAIR REMOVER
K022341 · GEX
Terabyte Co.
General & Plastic Surgery · 193d
Cleared Jan 27, 2003
ERA 3000
K022360 · DTA
Biotronik, Inc.
Cardiovascular · 192d
Cleared Jan 27, 2003
CELSIUS CONTROL SYSTEM
K022366 · NCX
Innercool Therapies
Neurology · 189d
Cleared Jan 27, 2003
PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED,...
K022929 · MKJ
Cardiac Science, Inc.
Cardiovascular · 145d
Cleared Jan 27, 2003
CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG
K022951 · GEX
Candela Corp.
General & Plastic Surgery · 144d
Cleared Jan 27, 2003
SPEEDICATH
K023254 · GBM
Coloplast Corp.
Gastroenterology & Urology · 119d
Cleared Jan 27, 2003
SLT VENOUS FIBER DELIVERY SYSTEMS, MODEL:...
K023624 · GEX
Surgical Laser Technologies, Inc.
General & Plastic Surgery · 90d
Cleared Jan 27, 2003
PALOMAR Q-YAG ND:YAG LASER SYSTEM
K023967 · GEX
Palomar Medical Technologies, Inc.
General & Plastic Surgery · 59d
Cleared Jan 27, 2003
VACUETTE TRACE ELEMENTS TUBES
K023971 · JKA
Greiner Bio-One Vacuette North America
Chemistry · 59d
Cleared Jan 27, 2003
ACCURA ELITE SHUNT SYSTEM
K024040 · JXG
Phoenix Biomedical Corp.
Neurology · 52d
Cleared Jan 27, 2003
PHOENIX UNIVERSAL SHUNT SYSTEM
K024101 · JXG
Phoenix Biomedical Corp.
Neurology · 46d
Cleared Jan 27, 2003
LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE
K030002 · FPA
Abbott Laboratories
General Hospital · 25d
Cleared Jan 24, 2003
MUCOGRAFT
K012423 · NPL
Ed. Geistlich Soehne AG Fuer...
Dental · 543d
Cleared Jan 24, 2003
GOOD LUBRICATIONS
K020586 · KMJ
Biofilm, Inc.
General Hospital · 336d
Cleared Jan 24, 2003
FLOWLINE BIOPORE EPTFE VASCULAR GRAFT
K021547 · DSY
Jotec GmbH
Cardiovascular · 259d
Cleared Jan 24, 2003
40LPM ABDOMINAL INSUFFLATOR, CATALOG # 72-00203-0
K022052 · HIF
Northgate Technologies, Inc.
Obstetrics & Gynecology · 214d