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
163033–163056 of 175,230
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 1981
CONFI-DRY ADULT UROABSORBENT PADS
K811766 · HHD
Personal Products Co.
Obstetrics & Gynecology · 18d
Cleared Jul 10, 1981
EMIT-CAD PROCAINAMIDE ASSAY
K811770 · LAR
Syva Co.
Toxicology · 18d
Cleared Jul 10, 1981
A.D.T. REUSABLE BONE MARROW NEEDLE
K811771 · GAA
Lab Industries, Inc.
General & Plastic Surgery · 18d
Cleared Jul 10, 1981
OPEN LOOP AMBULATORY INFUSION DEVICE
K811774 · FRN
Cardiac Pacemakers, Inc.
General Hospital · 17d
Cleared Jul 10, 1981
KALLESTAD ANTISERA TO PHENYTOIN
K811775 · DLP
Kallestad Laboratories, Inc.
Toxicology · 17d
Cleared Jul 10, 1981
KALLESTAD QUANTICOAT 125 DIGOXIN
K811776 · DPO
Kallestad Laboratories, Inc.
Toxicology · 17d
Cleared Jul 10, 1981
TENSIOMETER
K811781 · DXN
Vivitek, Inc.
Cardiovascular · 17d
Cleared Jul 10, 1981
QUANTAPHASE T-4 RIA
K811787 · CDX
Bio-Rad
Chemistry · 17d
Cleared Jul 10, 1981
ARRYTHMIA PRINTER OPTION
K811792 · DSI
American Edwards Laboratories
Cardiovascular · 16d
Cleared Jul 10, 1981
FERRITIN RIA KIT
K811804 · DBF
Amersham Corp.
Chemistry · 16d
Cleared Jul 10, 1981
AUTOPAK-12 FERRITIN KIT
K811808 · DBF
Micromedic Systems
Chemistry · 15d
Cleared Jul 10, 1981
ANTI-ARRHYTHMIC CONTROL LEVELS I & II
K811809 · DIF
Environmental Chemical Specialties
Chemistry · 15d
Cleared Jul 10, 1981
TDM ANTI-CONVULSANT CONTROL LEVELS I-II
K811811 · DIF
Environmental Chemical Specialties
Chemistry · 15d
Cleared Jul 10, 1981
ORANGE G-6
K811825 · HZH
Surgipath
Pathology · 11d
Cleared Jul 10, 1981
EOSIN Y
K811826 · HYB
Surgipath
Pathology · 11d
Cleared Jul 10, 1981
VNACE FASCIAL DILATOR SET
K811833 · KOE
Vance Products, Inc.
Gastroenterology & Urology · 10d
Cleared Jul 10, 1981
I.V. ADMINISTRATION SET
K811837 · FPA
Medisystems Corp.
General Hospital · 9d
Cleared Jul 10, 1981
COAT-A-COUNT GENTAMICIN RIA KIT
K811844 · DJB
Diagnostic Products Corp.
Chemistry · 9d
Cleared Jul 10, 1981
FLUOROMATIC THEOPHYLLINE FIA
K811856 · LER
Bio-Rad
Chemistry · 9d
Cleared Jul 10, 1981
SELECT-A-FLOW
K811857 · KNK
Wenmar Intl. Corp.
Chemistry · 9d
Cleared Jul 10, 1981
HI-LO TEMP ESOPHAGEAL STETHOSCOPE
K811862 · BZT
Mallinckrodt Critical Care
Anesthesiology · 9d
Cleared Jul 09, 1981
ELECTRONIC APGAR TIMER
K811424 · LHB
Pt&E
General Hospital · 48d
Cleared Jul 02, 1981
ENDOCARDIAL ELECTRODE
K810928 · DTB
Vitatron Medical BV
Cardiovascular · 87d
Cleared Jul 02, 1981
RADIATION STERILIZED ADMIN. SET
K811078 · FPA
Travenol Laboratories, S.A.
General Hospital · 73d