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
150889–150912 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Oct 15, 1984
LAURIER SANITARY NAPKIN
K843318 · HHD
Kao Corp.
Obstetrics & Gynecology · 52d
Cleared Oct 15, 1984
RIA PANTY SHIELDS
K843401 · HHD
Paul Hartmann Corp.
Obstetrics & Gynecology · 46d
Cleared Oct 13, 1984
PERCUTANEOUS BALLOON
K832753 · DSP
Smec, Inc.
Cardiovascular · 425d
Cleared Oct 12, 1984
INTRAUTERINE DEVICE REMOVER
K842295 · HHF
Premier Dental Products Co.
Obstetrics & Gynecology · 123d
Cleared Oct 12, 1984
MICROSPAN -PH MONITOR
K842303 · CBF
Biochem International, Inc.
Anesthesiology · 123d
Cleared Oct 12, 1984
ACT, SUCTION TIP
K842779 · BSY
Edward Manougian, M.D.
Anesthesiology · 88d
Cleared Oct 12, 1984
BEMCO PORTABLE OXYGEN INHALATOR
K843585 · CAN
Bemco, Inc.
Anesthesiology · 31d
Cleared Oct 12, 1984
A-T TENS BELT
K843793 · GZJ
A-T Surgical Mfg. Co., Inc.
Neurology · 28d
Cleared Oct 12, 1984
N2 TEST
K843840
Erich Jaeger, Inc.
Cardiovascular · 11d
Cleared Oct 12, 1984
CO2 TEST
K843844 · CCK
Erich Jaeger, Inc.
Anesthesiology · 11d
Cleared Oct 12, 1984
CO TEST
K843845 · CCJ
Erich Jaeger, Inc.
Anesthesiology · 11d
Cleared Oct 12, 1984
O2 TEST
K843847 · CCL
Erich Jaeger, Inc.
Anesthesiology · 11d
Cleared Oct 11, 1984
DIAGEM DIGITAL BLOOD GLUCOSE MONITOR
K841648 · JJQ
Forward Medical Supplies
Chemistry · 174d
Cleared Oct 11, 1984
GASTRIN RADIOIMMUNOASSAY TEST KIT
K842965
Serono Diagnostics, Inc.
Chemistry · 76d
Cleared Oct 11, 1984
RENIN RADIOIMMUNOASSAY TEST KIT
K842966 · CIB
Serono Diagnostics, Inc.
Chemistry · 76d
Cleared Oct 11, 1984
ATAC 2000
K843059 · JJE
Turpen Laboratory Systems, Inc.
Chemistry · 69d
Cleared Oct 11, 1984
TUGS-TRANSPORTABLE UNIV. GRADIENT SUCT
K843081 · JCX
Creative Medical Laboratories, Inc.
General & Plastic Surgery · 66d
Cleared Oct 11, 1984
GREEN CROSS URINARY DRAINAGE BAG
K843117 · KNX
Tech-Cons Ltd., Intl.
Gastroenterology & Urology · 64d
Cleared Oct 11, 1984
PHENYTOIN ACA ANALYTICAL TEST PACK
K843209 · DIP
E.I. Dupont DE Nemours & Co., Inc.
Toxicology · 57d
Cleared Oct 11, 1984
DK*300 VOLUMETRIC INFUSION CONTROLLER
K843254 · LDR
Deka Research & Development Corp.
General Hospital · 52d
Cleared Oct 11, 1984
DAVOL GAUDERER-PONSKY PERCUTAN-ENDOSCOP
K843305 · KNT
C.R. Bard, Inc.
Gastroenterology & Urology · 49d
Cleared Oct 11, 1984
URI TX-100 MULTICHANNEL THERMOCOUPLE
K843381 · FLL
Uri Therm-X, Inc.
General Hospital · 44d
Cleared Oct 11, 1984
GAUDERER GASTROSTOMY BUTTON
K843392 · KNT
American V. Mueller
Gastroenterology & Urology · 43d
Cleared Oct 11, 1984
ENCORE TSH REAGENT
K843395 · JLW
Hybritech, Inc.
Chemistry · 43d