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
78049–78072 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
K012371 · DDG
Roche Diagnostics Corp.
Immunology · 55d
Cleared Sep 19, 2001
TINA-QUANT TRANSFERRIN VER.2
K012393 · DDG
Roche Diagnostics Corp.
Immunology · 54d
Cleared Sep 19, 2001
BIFURCATED VACCINATING NEEDLE
K012515 · SCL
Precision Medical Products, Inc.
General Hospital · 44d
Cleared Sep 19, 2001
M71 POWER WHEELCHAIR
K012927 · ITI
Invacare Corp.
Physical Medicine · 19d
Cleared Sep 18, 2001
HARRISON HAND HELD ADJUSTING INSTRUMENT
K010851 · LXM
Harrison Cbp Seminars
Physical Medicine · 181d
Cleared Sep 18, 2001
G7 AUTOMATED HPLC ANALYZER
K011434 · LCP
Tosoh Medics, Inc.
Hematology · 131d
Cleared Sep 18, 2001
HANDPIECE SHEATH-MODEL #A910
K011929 · GEI
Aaron Medical, Inc.
General & Plastic Surgery · 90d
Cleared Sep 18, 2001
DS30 HCY BLOOD COLLECTION TUBES
K012152 · GIM
Drew Scientific , Ltd.
Chemistry · 69d
Cleared Sep 18, 2001
ADVANCE MEDICAL DESIGNS FLUID POUCH
K012168 · KKX
Advance Medical Designs, Inc.
General Hospital · 68d
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