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

JFH 1979-11-15

PAP RIA KIT

Applicant Nuclear Medical Systems, Inc.

K-Number K791735

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N/A 1979-11-15

BIOBRANE BRAND TEMPORARY WOUND DRESSING

Applicant Hall-Woodroof, Inc.

K-Number K791184

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DXY 1979-11-15

MEDTRONIC MODELS 5984/5985

Applicant Medtronic Vascular

K-Number K791316

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JSS 1979-11-13

AMS ENTEROBACTERIACEASE CARE

Applicant Vitek Systems, Inc.

K-Number K791932

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CEK 1979-11-13

SMAC (SEQUENTIAL MULT. ANALYSIS COMP.

Applicant Fisher Scientific Co., LLC

K-Number K792138

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DPE 1979-11-13

TECHNICON FAST-LC SYS. ANTICONVU DRUGS

Applicant Technicon Instruments Corp.

K-Number K791979

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DYB 1979-11-13

PERCUTANEOUS SHEATH (MULTI-CATH)SIDE

Applicant Stanco Medical, Inc.

K-Number K792170

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DRX 1979-11-13

BARD BIOMEDICAL PRINTED SILVER ELECTRODE

Applicant C.R. Bard, Inc.

K-Number K792040

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JLW 1979-11-13

THYROID STIMULATING HORMONE

Applicant Radioimmunoassay, Inc.

K-Number K792154

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GLZ 1979-11-13

TORCH BIO-BEAD SCREEN KIT

Applicant Litton Bionetics

K-Number K791618

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EFQ 1979-11-13

LAP SPONGES

Applicant Carwild Corp.

K-Number K791872

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KOD 1979-11-13

NELATON CATHETER

Applicant American Hospital Supply Corp.

K-Number K792038

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