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
77545–77568 of 174,955
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 18, 2001
BDPROBETEC ET CT/GC AMPLIFIED DNA ASSAY
K012351 · LSL
Becton, Dickinson & CO
Microbiology · 55d
Cleared Sep 18, 2001
MACROPORE FX, PS, NS, LP
K012413 · JEY
Macropore Biosurgery, Inc.
Dental · 50d
Cleared Sep 18, 2001
DISPOSABLE POWDER FREE VINYL PATIENT EXAMINATION GLOVES
K012711 · LYZ
Shijiazhuang Brilliance Plastic Co.,...
General Hospital · 35d
Cleared Sep 18, 2001
LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2,...
K012722 · GGN
Bio-Rad
Hematology · 34d
Cleared Sep 18, 2001
HEMOSIL RECOMBI PLASTIN
K012768 · GJS
Instrumentation Laboratory CO
Hematology · 32d
Cleared Sep 18, 2001
GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER
K012775 · KPS
GE Medical Systems
Radiology · 29d
Cleared Sep 18, 2001
MP3CF ELECTRIC WHEELCHAIR
K012802 · ITI
Merits Health Products., Inc.
Physical Medicine · 28d
Cleared Sep 18, 2001
V*CARE MANUAL RESUSCITATOR
K012842 · BTM
Ventlab Corp.
Anesthesiology · 26d
Cleared Sep 18, 2001
GREEN NITRILE POWDER-FREE MEDICAL EXMAINATION GLOVE
K012899 · LZA
Best Manufacturing Company
General Hospital · 20d
Cleared Sep 18, 2001
RANDOX GENTAMICIN
K012978 · LCD
Randox Laboratories, Ltd.
Toxicology · 74d
Cleared Sep 17, 2001
INFARED EAR THERMOMETER, MODEL TH8 SERIES
K011059 · FLL
Radiant Innovation, Inc.
General Hospital · 164d
Cleared Sep 17, 2001
POWDER-FREE GREEN BARRIER-PRO SYNTHETIC BUTADIENE COPOLYMER EXAMINATION GLOVE
K011613 · LZA
Shield Gloves Manufacturer (M) Sdn Bhd
General Hospital · 115d
Cleared Sep 17, 2001
SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES,...
K011911 · FFK
Richard Wolf Medical Instruments Corp.
Gastroenterology & Urology · 90d
Cleared Sep 17, 2001
FIRST SPEP
K012032 · DYH
Bisco, Inc.
Dental · 80d
Cleared Sep 17, 2001
CLINCARE LATEX SURGEON'S GLOVE
K012067 · KGO
Ttk Healthcare , Ltd.
General Hospital · 77d
Cleared Sep 17, 2001
OPUS MAGNUM ANCHOR & INSERTER
K012125 · HTY
Opus Medical, Inc.
Orthopedic · 73d
Cleared Sep 17, 2001
ACON BZO ONE STEP BENZODIAZEPINES TEST STRIP
K012300 · JXM
ACON Laboratories, Inc.
Toxicology · 59d
Cleared Sep 17, 2001
POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN...
K012558 · LYY
Matang Mfg. Sdn. Bhd.
General Hospital · 40d
Cleared Sep 17, 2001
MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM
K012898 · DTR
Cobe Cardiovascular, Inc.
Cardiovascular · 19d
Cleared Sep 14, 2001
COPELAND MB RESURFACING HUMERAL HEADS
K010657 · HSD
Biomet Manufacturing, Inc.
Orthopedic · 192d
Cleared Sep 14, 2001
COPELAND MB/HA RESURFACING HUMERAL HEADS
K010827 · HSD
Biomet Orthopedics, Inc.
Orthopedic · 178d
Cleared Sep 14, 2001
VERTEX ETCHANT
K010849 · EBF
Apex Dental Materials, Inc.
Dental · 177d
Cleared Sep 14, 2001
E-STETH ELECTRONIC STETHOSCOPE
K011898 · DQD
E-Med Innovations, Inc.
Cardiovascular · 88d
Cleared Sep 14, 2001
ALLERSHARP ALLERGY SKIN TESTER
K011979 · SCL
Hmb Medical Concepts, Ltd.
General Hospital · 81d