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

CDP 1979-05-15

CHROMATOGRAPHY TUBES

Applicant Miles Laboratories, Inc.

K-Number K790581

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CED 1979-05-15

CENTRIFICHEM INORGANIC PHOSPHORUS

Applicant Union Carbide Corp.

K-Number K790662

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ITI 1979-05-15

PERMOBIL SUPERIOR

Applicant Saab-Scania of America, Inc.

K-Number K790859

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FAP 1979-05-14

ULTRALITE UROSYSTEM, MODELS GU-1 & GU-2

Applicant American Medical Systems, Inc.

K-Number K790519

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EXD 1979-05-14

COLOSTOMY DEVICE W/ PRESSURE LID

Applicant Vabar Corp.

K-Number K790750

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KZH 1979-05-14

PISTORMATIC

Applicant Zelby, Burstein, Hartman & Burstein

K-Number K790104

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FWZ 1979-05-14

THE SURGICAL ASSISTANT

Applicant Instrument Makar, Inc.

K-Number K790674

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N/A 1979-05-14

ENCLOSED CASE CART

Applicant Hamilton Industries, Inc.

K-Number K790871

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HRY 1979-05-14

PLATFORM TCCK TOTAL KNEE

Applicant Biomet, Inc.

K-Number K790762

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DTD 1979-05-14

IMPLANTABLE HEART LEAD TERMINAL ADAPTER

Applicant Arco Medical Products Co.

K-Number K790436

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HCC 1979-05-14

THE BIONIC EXERCISER

Applicant Scudder Molner Instruments

K-Number K790746

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EBW 1979-05-14

OPTIONAL ACCESSORY FOOT SWITCH MODEL 100

Applicant Applied Medical Research

K-Number K790322

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