Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k) Clearances

510(k) cleared devices tracked by MedTracker

FRN 1981-07-10

OPEN LOOP AMBULATORY INFUSION DEVICE

Applicant Cardiac Pacemakers, Inc.

K-Number K811774

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KOE 1981-07-10

VNACE FASCIAL DILATOR SET

Applicant Vance Products, Inc.

K-Number K811833

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JHI 1981-07-10

HCG RADIOIMMUNOASSAY KIT (125I)

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K811421

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CEM 1981-07-10

SODIUM/POTASSIUM REAGENT KITS

Applicant Chem-Elec, Inc.

K-Number K811310

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LAR 1981-07-10

EMIT-CAD PROCAINAMIDE ASSAY

Applicant Syva Co.

K-Number K811770

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DSI 1981-07-10

ARRYTHMIA PRINTER OPTION

Applicant American Edwards Laboratories

K-Number K811792

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DHN 1981-07-10

HEP-2-CRITHIDIA LUCILIAE ANA TEST KIT

Applicant Scripps-Miles, Inc.

K-Number K811714

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GZJ 1981-07-10

INSIGHT

Applicant Staodynamics, Inc.

K-Number K811345

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CFT 1981-07-10

MRI PROLACTIN RIA KIT

Applicant Microanalytic Research, Inc.

K-Number K810949

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KCW 1981-07-10

EPILATOR, BLEND-MODEL EB-200 & ET-1

Applicant Rcx-Western, Inc.

K-Number K811503

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IXO 1981-07-10

SIEMENS ANGIOTRON

Applicant Siemens Corp.

K-Number K811587

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HZH 1981-07-10

ORANGE G-6

Applicant Surgipath

K-Number K811825

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