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

LBS 1980-09-09

HDL CHOLESTEROL TEST KIT

Applicant Mallinckrodt Critical Care

K-Number K801726

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FQM 1980-09-09

FINGER PAINGUARD CAT.#193-194

Applicant Pollak (Intl.), Ltd.

K-Number K802015

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KQJ 1980-09-09

SIGMA PROCEDURE #880 FIBRINOGIN/PLASMA

Applicant Sigma Chemical Co.

K-Number K801926

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KXF 1980-09-09

PREP SET CAT.#908

Applicant Pollak (Intl.), Ltd.

K-Number K802020

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BYE 1980-09-09

VITAL SIGNS PEEP VALVE

Applicant Vital Signs, Inc.

K-Number K802070

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DTI 1980-09-09

HANCOCK * OBTURATORS

Applicant Hancock Laboratories, Inc.

K-Number K801885

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LDQ 1980-09-09

PLASTIC DISPOSABLE RAZOR CAT.#1017,1018

Applicant Pollak (Intl.), Ltd.

K-Number K802003

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JJY 1980-09-09

ASSURE LEVEL II PROD. #30172

Applicant Warner-Lambert Co.

K-Number K801539

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KNX 1980-09-09

TRIBAG, URINE BAG SYSTEM #1109,& 1301-12

Applicant Pollak (Intl.), Ltd.

K-Number K802012

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DXY 1980-09-09

INSULATING SHEATH

Applicant Cordis Corp.

K-Number K801910

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FMH 1980-09-09

URINE SPECIMEN CONTAINER #'S 1013-1016

Applicant Pollak (Intl.), Ltd.

K-Number K802002

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KYZ 1980-09-09

SAPCRILL THERMODETECT BREAST SCANNER DEV

Applicant California Cardiac Systems, Inc.

K-Number K801573

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