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

DQC 1980-04-16

MODEL 100 SPECTRAVIEW

Applicant Edwards Laboratories

K-Number K800655

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FPA 1980-04-16

Y-TYPE INFUSION SET (2 LEAD)

Applicant Haemonetics Corp.

K-Number K800358

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FPA 1980-04-16

MCGAW/EPIC I.V. ADMIN. SET

Applicant American Hospital Supply Corp.

K-Number K800403

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GEN 1980-04-16

NORSEN DEBRIDER

Applicant Medline Industries, Inc.

K-Number K800647

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DXY 1980-04-16

CYBERLITH IMPLANTABLE PULSE GEN. #253-02

Applicant Intermedics, Inc.

K-Number K800644

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CGR 1980-04-16

AMERLEX CORTISOL RIA KIT

Applicant Amersham Corp.

K-Number K800700

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FXP 1980-04-16

SHIELD PERFECT FIT; DURA-FIT, DISPOS.

Applicant American Convertors Div., American Pharmaseal

K-Number K800528

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DRS 1980-04-16

MEDI-TRACE DISPOSABLE DOMES/MONITORING

Applicant Graphic Controls Corp.

K-Number K800706

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LDF 1980-04-16

USCI BIPOLAR BALLON PACING ELECTRODE

Applicant C.R. Bard, Inc.

K-Number K800298

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FYF 1980-04-16

SHIELD LUCKY CAP; BLOSSOM BOUFFANT CAP

Applicant American Convertors Div., American Pharmaseal

K-Number K800511

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KLE 1980-04-10

ANTERIOR & POST. RESTORATIVE PASTE SYS.

Applicant American Dental Research

K-Number K800389

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EBC 1980-04-10

PAINT-ON-RESTORATIVE W/FISSURE SEALER

Applicant American Dental Research

K-Number K800391

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