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

GAA 1983-03-24

STERILE, DISPOSABLE, HYPODERMIC NEEDLES

Applicant Abco Dealers, Inc.

K-Number K830378

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CJF 1983-03-24

FLOW-PAC ALKALINE PHOSPHATE REAGENT SET

Applicant Amresco, Inc.

K-Number K830535

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KEM 1983-03-24

CLARIFIER-RICHARD-ALLAN

Applicant Richard-Allan Medical Ind., Inc.

K-Number K830627

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FRN 1983-03-24

PERSONAL MEDICATION INFUSER

Applicant Pacesetter Systems

K-Number K830570

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N/A 1983-03-24

OMED IDENT-I-BAND

Applicant Omega-Med Intl., Inc.

K-Number K830484

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DZE 1983-03-24

TITANALOY SUBMERSIBLE IMPLANT SYSTEM

Applicant Boehringer/Miter, Inc.

K-Number K830414

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LIT 1983-03-24

USCI GRUNTZIG DILACA BALLOON DILATION

Applicant C.R. Bard, Inc.

K-Number K830608

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CEK 1983-03-24

FLOW-PAC TOTAL PROTEIN REAGENT SET

Applicant Amresco, Inc.

K-Number K830538

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CGX 1983-03-24

KINETIC CREATININE

Applicant American Monitor Corp.

K-Number K830447

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CGX 1983-03-24

CREATININE

Applicant Pointe Scientific, Inc.,

K-Number K830556

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KXS 1983-03-24

ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE

Applicant Hoffmann-La Roche, Inc.

K-Number K830461

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DWS 1983-03-24

KELLY-WICK TANNELER

Applicant Intl. Medical Prosthetics Research

K-Number K830471

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