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

FRN 1982-01-25

OPEN LOOP AMBULATORY INSULIN INFUSION

Applicant Cardiac Pacemakers, Inc.

K-Number K820073

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FQH 1982-01-25

IRRIGATION SYRINGE

Applicant Karoco Intl.

K-Number K810185

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FAE 1982-01-25

ESKA JONAS SILICONE-SILVER PENILE PROST

Applicant Dacomed Corp.

K-Number K820081

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HEB 1982-01-25

PETAL SOFT PLASTIC APPLICATOR TAMPAX

Applicant Tampax, Inc.

K-Number K813642

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BZK 1982-01-22

SPIROX A

Applicant Cairco , Ltd.

K-Number K812959

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KGO 1982-01-22

RADIATION STERILIZED SURGEON'S GLOVES

Applicant Travenol Laboratories, S.A.

K-Number K813565

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HPJ 1982-01-22

LASER PHOTOCOAGULATOR ARGON MED. LASER

Applicant American Laser Corp.

K-Number K813429

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BZG 1982-01-22

CXD 400

Applicant Cdx Corp.

K-Number K820036

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DXQ 1982-01-22

CONPHAR, WALL ANEROID SPHYGMOMANOMETER

Applicant Conphar, Inc.

K-Number K813303

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N/A 1982-01-22

OMS ANTERIOR CHAMBER INFUSION NEEDLE

Applicant Optical Micro Systems, Inc.

K-Number K813483

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NAB 1982-01-22

COMFORT CUSHION DRY BURN PAD III

Applicant American Convertors Div., American Pharmaseal

K-Number K813419

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DJP 1982-01-22

AGGLUTEX AMPHETAMINE TEST KIT

Applicant Hoffmann-La Roche, Inc.

K-Number K812986

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