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

DRT 1980-10-31

WISCONSIN HEART RATE MONITOR

Applicant Lunar Radiation Corp.

K-Number K802182

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CIZ 1980-10-31

ANDROSTENEDIONE RADIOIMMUNOASSAY KIT

Applicant Diagnostics Biochem Canada, Inc.

K-Number K801729

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FJI 1980-10-31

HOLLO FIBER DIALYZER

Applicant Renal Devices, Inc.

K-Number K801559

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CGR 1980-10-31

ARIA II 125 I CORTISOL

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K802380

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FLN 1980-10-31

INFUSSION ALARM SYSTEM I.A.S. CAT.#1118

Applicant Pollak (Intl.), Ltd.

K-Number K802011

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KPY 1980-10-31

MOTI PROTECTIVE X-RAY MASK

Applicant Moti Enterprises, Inc.

K-Number K802377

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JSM 1980-10-31

VIRAL TRANSPORT MED. (46-995-04)

Applicant Flow Laboratories, Inc.

K-Number K802303

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JJF 1980-10-31

WASH SOLUTION KIT, #88102

Applicant Hi Chem, Inc.

K-Number K802264

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DMT 1980-10-31

EMIT-STM ETHYL ALCOHOL ASSAY

Applicant Syva Co.

K-Number K802621

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JTO 1980-10-31

BETA LACTAMASE REAGENT DISK

Applicant Carr-Scarborough Microbiologicals, Inc.

K-Number K802566

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GAD 1980-10-31

ARTHROSCOPIC FAT PAD RETRACTOR

Applicant The Anspach Effort, Inc.

K-Number K802599

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GWM 1980-10-31

CHEEK EPIDURAL SCREW

Applicant Codman & Shurtleff, Inc.

K-Number K802137

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