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

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176,076 results
163873–163896 of 176,076
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Jul 10, 1981
VIRGO IPA FOR DETECTION OF PHENYTOIN
K811745 · DIP
Electro-Nucleonics Laboratories, Inc.
Toxicology · 21d
Cleared Jul 10, 1981
KING DIAGNOSTICS CHOLESTEROL-FE TEST
K811746 · CHO
King Diagnostics, Inc.
Chemistry · 18d
Cleared Jul 10, 1981
KING DIAGNOSTICS CHOLESTEROL TEST
K811747 · CGO
King Diagnostics, Inc.
Chemistry · 18d
Cleared Jul 10, 1981
KING DIAGNOSTICS CALCIUM TEST
K811748 · CIC
King Diagnostics, Inc.
Chemistry · 18d
Cleared Jul 10, 1981
KING DIAGNOSTICS PHOSPHORUS TEST
K811749 · CEO
King Diagnostics, Inc.
Chemistry · 18d
Cleared Jul 10, 1981
CHOLESTEROL DETERMINATION
K811760 · CHH
Biorent Diagnostic, Inc.
Chemistry · 18d
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