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 1978-06-22

IMPROVED DISPOSABLE HYPODERMIC NEEDLE

Applicant Pharmaseal Div., Baxter Healthcare Corp.

K-Number K780887

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FKP 1978-06-22

SINGLE PATIENT SYSTEMS

Applicant Extracorporeal Medical Specialities, Inc.

K-Number K780682

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JDG 1978-06-22

PROSTHESIS, HIP, CATHCART, SCHILLER MOD.

Applicant Depuy, Inc.

K-Number K780773

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JPK 1978-06-22

ARANTROL

Applicant Aranco Diagnostic Laboratories, Inc.

K-Number K780835

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GEI 1978-06-22

SINGLE USE ACTIVE ELECTRODE HANDLE

Applicant Aspen Laboratories, Inc.

K-Number K780978

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GEI 1978-06-22

SINGLE USE NEEDLE ELECTRODE

Applicant Aspen Laboratories, Inc.

K-Number K780975

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IYX 1978-06-22

CLINICAL ACQUISITION MODULE

Applicant Analytical Development Assoc. Corp.

K-Number K780971

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EHL 1978-06-22

DENTAL ABRASIVE DEVICE

Applicant Cavitron Corp.

K-Number K780811

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JRY 1978-06-22

EB-VCA, TEST, ANTIBODY, FLUORESCENT

Applicant Litton Bionetics

K-Number K780925

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ETD 1978-06-22

OTOLOGICAL VENTILATION TUBES

Applicant Mcghan Medical Corp.

K-Number K780956

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GWF 1978-06-22

STIMULATOR MODEL 8021

Applicant Life-Tech Instruments, Inc.

K-Number K780539

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EJJ 1978-06-22

LEE-ALLOY

Applicant Lee Pharmaceuticals

K-Number K780967

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