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

JAK 1978-11-03

SCANNER, CT 0450

Applicant Pfizer Medical Systems, Inc.

K-Number K781752

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KYJ 1978-11-03

GAMMA RADIATION STERILIZATION PRECEDURE

Applicant Cutter Laboratories, Inc.

K-Number K781668

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KGO 1978-11-03

LATEX, IN-HOUSE COMPOUNDED

Applicant Arbrook Mfg. Corp.

K-Number K781847

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HJE 1978-11-03

EXAMINER 10

Applicant American Sterilizer Co.

K-Number K781698

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CIT 1978-11-03

REAGENT SET, U.V. ENZMATIC KINETIC, SGOT

Applicant Medical Analysis Systems, Inc.

K-Number K781725

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KNX 1978-11-03

AKRON MALE EXTERNAL CATHETER

Applicant Latex Ind., Inc.

K-Number K781433

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HME 1978-11-03

MAXI-CHAIR

Applicant Surgical Mechanical Research, Inc.

K-Number K781801

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CHH 1978-11-03

REAGENT SET, CHOLESTEROL

Applicant Medical Analysis Systems, Inc.

K-Number K781721

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GWJ 1978-11-03

AMPLAID MARK 4 AND MARK 5

Applicant Amplaid USA, Inc.

K-Number K781667

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HMP 1978-11-03

ISO-CARE KIT

Applicant Nice-Pak Products, Inc.

K-Number K781539

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HKP 1978-11-03

CLINITEX VIS-X ASPIRATING ACCESSORY

Applicant Varian Assoc., Inc.

K-Number K780852

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CEK 1978-11-03

REAGENT SET, TOTAL PROTEIN

Applicant Medical Analysis Systems, Inc.

K-Number K781722

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