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

ESD 1978-06-14

PRIMO CEDM (BEHIND THE EAR)

Applicant Argosy Intl. (Usa), Inc.

K-Number K780918

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GDY 1978-06-14

ARTERIAL LINE KIT

Applicant Argon Medical Corp.

K-Number K780871

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JAK 1978-06-14

CT5137 HIGH RESOLUTION OPTION

Applicant Emi Medical, Inc.

K-Number K780928

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ESD 1978-06-14

PRIMO CE (BEHIND THE EAR)

Applicant Argosy Intl. (Usa), Inc.

K-Number K780917

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JAK 1978-06-14

5543 INDEPENDENT VIEWING SYSTEM

Applicant Emi Medical, Inc.

K-Number K780930

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JMX 1978-06-13

NINHYDRIN REAGENT KIT

Applicant Beckman Instruments, Inc.

K-Number K780847

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ITQ 1978-06-13

FRACTURE BRACING

Applicant Hosmer Dorrance Corp.

K-Number K780892

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JJW 1978-06-13

ARMTROL AND FERMTROL

Applicant Biotron , Ltd.

K-Number K780802

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N/A 1978-06-13

MILK BATH CONCENTRATE

Applicant Sparta Instrument Corp.

K-Number K780258

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DSK 1978-06-13

GOULD-STATHAM SP1405 PRESSURE MONITOR

Applicant Gould, Inc.

K-Number K780798

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CKA 1978-06-13

SGPT/ALT REAGENT SYSTEM

Applicant American Monitor Corp.

K-Number K780791

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CHH 1978-06-13

HDL CHOLESTEROL

Applicant Macomb Chemical Co.

K-Number K780659

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