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.

175,730 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,230 results
149497–149520 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 27, 1985
BSI MODEL MCT 7000-THERMAL IMAGING SYSTEM
K850534 · LHQ
Bales Scientific, Inc.
Radiology · 16d
Cleared Feb 26, 1985
HERPES VIRUS AGGLUTINATION TEST
K842887 · GQO
Scientific Research
Microbiology · 218d
Cleared Feb 26, 1985
PHYSIO GAS ANALYZER
K843423 · LLL
Research Medical, Inc.
Immunology · 179d
Cleared Feb 26, 1985
OPHTHALMIC A-SCAN A-2000 SONOME
K843696 · IYO
Sonomed Technology, Inc.
Radiology · 160d
Cleared Feb 26, 1985
VARIABLE TEMPERATURE CAUTERY DEVICE
K843974 · GEI
National Patent Development Corp.
General & Plastic Surgery · 138d
Cleared Feb 26, 1985
DMI CONSOLE
K844317 · LLZ
Dimensional Medicine, Inc.
Radiology · 112d
Cleared Feb 26, 1985
SAV-A-LIFE
K844622 · CAN
Southern Medical Products, Inc.
Anesthesiology · 91d
Cleared Feb 26, 1985
EMG REPORT GENERATOR
K844681 · JXE
Microsystem Controls
Neurology · 88d
Cleared Feb 26, 1985
SELECTRON LDR SELECTRON LOW DOSE RATE
K844714 · JAQ
Radiochemical Co.
Radiology · 85d
Cleared Feb 26, 1985
CANAL WALL PROSTHESIS
K844960 · FZD
Richards Medical Co., Inc.
General & Plastic Surgery · 67d
Cleared Feb 26, 1985
INCUS PROSTHESIS
K844961 · ETB
Richards Medical Co., Inc.
Ear, Nose, Throat · 67d
Cleared Feb 26, 1985
CRONEX SR342-QUANTA FAST DETAIL-INTENSI-SCREENS
K845030 · EAM
E.I. Dupont DE Nemours & Co., Inc.
Radiology · 61d
Cleared Feb 26, 1985
STERILE SUTURE REMOVAL KIT
K850325 · KDD
Excel Health Care Products
General & Plastic Surgery · 29d
Cleared Feb 26, 1985
STERILE FILM DRAPE FENESTRATED W/ADHESIVE PATCH
K850326 · KKX
Excel Health Care Products
General Hospital · 29d
Cleared Feb 26, 1985
PALL GAS LINE GUARDIAN FILTER
K850327 · CAH
Pall Biomedical Products Co.
General Hospital · 29d
Cleared Feb 26, 1985
STAT BLUE DISPOS. MANUAL RESUSCITATOR
K850436 · BTM
Vital Signs, Inc.
Anesthesiology · 21d
Cleared Feb 26, 1985
RENAL BIOPSY TRAY
K850438 · KNW
Packaging Technologies, Inc.
Gastroenterology & Urology · 21d
Cleared Feb 26, 1985
CONCEPT CAMERA DRAPE
K850462
Concept, Inc.
General & Plastic Surgery · 20d
Cleared Feb 26, 1985
ATTENDS INCONTINENT UNDERGARMENT
K850611 · EYQ
Procter & Gamble Mfg. Co.
Gastroenterology & Urology · 11d
Cleared Feb 25, 1985
A1 SYSTEME 8201/2
K841803 · GKL
Med USA
Hematology · 300d
Cleared Feb 25, 1985
GL ULTRASOUND Z/SL 8300
K843205 · IYO
Gl Ultrasound , Ltd.
Radiology · 195d
Cleared Feb 25, 1985
ENDOCYTE
K843941 · HFE
Gyneco, Inc.
Obstetrics & Gynecology · 139d
Cleared Feb 25, 1985
TENS-AID PREMIUM ELECTRODES
K843964 · GXY
Staodynamics, Inc.
Neurology · 137d
Cleared Feb 25, 1985
EUB-40
K844128 · JAF
Hitachi Medical Corp. of America
Radiology · 125d