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

IYO 1980-02-21

INTRACULA II

Applicant Kt Medical, Inc.

K-Number K800099

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KNO 1980-02-21

SKIL-CARE LEG PADS

Applicant Skil-Care Corp.

K-Number K800208

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DBE 1980-02-21

IMMUNOP. ANTISMOOTH MUSCLE ANTIBODY KIT

Applicant Clinical Sciences, Inc.

K-Number K800228

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BZQ 1980-02-21

RESPIRATION/APNEA AMPLIFIER MODEL 3105

Applicant Electronics For Medicine, Inc.

K-Number K792528

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DHR 1980-02-21

AUTOMATED RHEMATOID FACTOR TEST (ARFT)

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K800268

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KSF 1980-02-21

RH-HR NEGATIVE CONTROL REAGENT

Applicant Gotham Biologics, Inc.

K-Number K800239

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CHH 1980-02-21

LINEAR ENZYMATIC CHOLESTEROL SYSTEM

Applicant Simmler, Inc.

K-Number K800199

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CGA 1980-02-21

LINEAR ENZYMATIC GLUCOSE SYSTEM

Applicant Simmler, Inc.

K-Number K800200

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BTC 1980-02-21

DISPOSAL LITER BREATHING BAG

Applicant Dryden Corp.

K-Number K800155

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DBM 1980-02-21

IMMUNOP. ANTIMITOCHONDRIAL ANTIBODY KIT

Applicant Clinical Sciences, Inc.

K-Number K800229

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EMA 1980-02-21

DENTALEEN

Applicant Denpac Corp.

K-Number K791160

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EMX 1980-02-21

NASOSTAT

Applicant Edward Weck, Inc.

K-Number K800175

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