Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

Filters: Cleared only ×
176,076 results
167977–168000 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Mar 03, 1980
BIOFEEDBACK DEVICES & ACCESSORIES
K792115 · HCC
M.O.E Electronics Research & Prod.
Neurology · 145d
Cleared Mar 03, 1980
FIAX TEST KIT FOR HERPES SIMPLEX VIRUS
K792559 · GQL
Intl. Diagnostic Technology
Chemistry · 83d
Cleared Mar 03, 1980
XR-710
K800063 · EAP
Pennwalt Corp.
Radiology · 52d
Cleared Mar 03, 1980
CRAWFORD LACRIMAL INTUBATION SET
K800089 · HNL
Jedmed Instrument Co.
Ophthalmic · 49d
Cleared Mar 03, 1980
PANOREX II DENTAL X-RAY UNIT
K800133 · EHD
Pennwalt Corp.
Radiology · 42d
Cleared Mar 03, 1980
SILASTIC SCLERAL SPONGE II W/CIRCLING BD
K800140 · HQX
Dow Corning Corp. Healthcare...
Ophthalmic · 42d
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