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
167137–167160 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 1980
SUN-TANNING BOOTHS
K800160 · FTC
World Wide Sun Systems, Inc.
Radiology · 39d
Cleared Mar 03, 1980
SANITARY NAPKINS MAXI-30
K800185 · HHD
No Frills Discount Foods, Inc.
Obstetrics & Gynecology · 34d
Cleared Mar 03, 1980
ACA CHOLESEROL/HDL CHOLESTEROL CALIBRAT.
K800206 · JIS
E.I. Dupont DE Nemours & Co., Inc.
Chemistry · 33d
Cleared Mar 03, 1980
PATIENT POSITIONING SYSTEM 1D OR 2D
K800223 · IWE
Laboratoire National D'Essais
Radiology · 28d
Cleared Mar 03, 1980
ML-800 CO2
K800227 · HHR
Merrimack Laboratories
Obstetrics & Gynecology · 27d
Cleared Mar 03, 1980
MICRO MEDICAL DATA SYSTEM II
K800242 · JQP
Micro/Tel., Inc.
Chemistry · 27d
Cleared Mar 03, 1980
EMIT AUTO CORTISOL ASSAY
K800245 · CGR
Syva Co.
Chemistry · 27d
Cleared Mar 03, 1980
FERRITIN RIA KIT
K800299 · DBF
Amersham Corp.
Immunology · 21d
Cleared Mar 03, 1980
ELECTRONIC PERINEOMETER
K800303 · HIR
Associates IN Biofeedback
Gastroenterology & Urology · 21d
Cleared Mar 03, 1980
ALPHA DETECTOR
K800319 · HCC
M.O.E Electronics Research & Prod.
Neurology · 20d
Cleared Mar 03, 1980
NEISSERIA GONORRHOEAE FLUORO-KIT
K800328 · GTH
Clinical Sciences, Inc.
Microbiology · 20d
Cleared Mar 03, 1980
CAMPYLOBACTER AGAR, CAT. NO. P2536
K800329 · JSJ
Gibco Laboratories Life Technologies,...
Microbiology · 19d
Cleared Mar 03, 1980
MODIFIED THAYER-MARTIN X AGAR
K800333 · JTY
Isle Media and Sterile Products, Inc.
Microbiology · 18d
Cleared Mar 03, 1980
MARTIN-LEWIS AGAR
K800334 · JTY
Isle Media and Sterile Products, Inc.
Microbiology · 18d
Cleared Mar 03, 1980
SANITARY NAPKINS, MAXI 30'S
K800372 · HHD
Giant Eagle Markets, Inc.
Obstetrics & Gynecology · 12d
Cleared Feb 29, 1980
DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG
K792282 · DKE
California Medical Developments, Inc.
Toxicology · 108d
Cleared Feb 29, 1980
NIASTAT
K800066 · DXN
Invivo Research Labs, Inc.
Cardiovascular · 49d
Cleared Feb 29, 1980
BASHAW CERVICAL IMMOBILIZER DEVICE
K800108 · IQK
Bashaw Custom Specialties, Inc.
Physical Medicine · 44d
Cleared Feb 29, 1980
CIRCAMED I
K800214 · DSH
Circadian, Inc.
Cardiovascular · 28d
Cleared Feb 29, 1980
MODEL 412 ELECTROFLUIDIC MANOMETER
K800222 · DXW
Med-Tek Corp.
Cardiovascular · 25d
Cleared Feb 29, 1980
OUTPUT DIGITAL DISPLAY MODULE, MOD. 611
K800360 · DSK
Output, Inc.
Cardiovascular · 9d
Cleared Feb 28, 1980
LEUKOFIX POROS
K792726 · FPX
Beiersdorf, Inc.
General & Plastic Surgery · 59d
Cleared Feb 28, 1980
USCI SAUVAGE EXS VASCULAR PROSTHESIS
K800149 · DSY
C.R. Bard, Inc.
Cardiovascular · 37d
Cleared Feb 28, 1980
DAHLBERG # AF BEHING THE EAR HEARING/AID
K800181 · ESD
Dahlberg Electronics, Inc.
Ear, Nose, Throat · 30d