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

DQY 1979-01-25

CATHETER, ARTERIAL LINE

Applicant Namic

K-Number K790083

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DXY 1979-01-24

ISOLATION SLEEVE, MODEL 349-01

Applicant Intermedics, Inc.

K-Number K790098

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DXY 1979-01-24

ISOLATION SLEEVE, MODEL 346-01

Applicant Intermedics, Inc.

K-Number K790101

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DXY 1979-01-24

ISOLATION SLEEVE, MODEL 347-01

Applicant Intermedics, Inc.

K-Number K790099

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DXY 1979-01-24

ISOLATION SLEEVE, MODEL 348-01

Applicant Intermedics, Inc.

K-Number K790100

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DSP 1979-01-23

PUMP, BALLOON MODEL 10

Applicant Avco Medical Products

K-Number K781848

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GYD 1979-01-23

TREMOR MONITOR

Applicant Columbus Instruments Intl. Corp.

K-Number K782036

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DTL 1979-01-23

STOPCOCKS, MANIFOLDS

Applicant Namic

K-Number K782095

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IME 1979-01-22

ICE PACK, REUSABLE FLEXIBLE

Applicant Ackrad Laboratories

K-Number K790009

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ESD 1979-01-22

HEARING AID, MODEL GB

Applicant Dahlberg Electronics, Inc.

K-Number K782121

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GBO 1979-01-22

SILASTIC NEPHROSTOMY SYSTEM

Applicant Dow Corning Corp. Healthcare Industries Materials

K-Number K781664

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CBO 1979-01-22

RESPIRATOR/GILL 1/SIMV

Applicant Chemetron Medical Products, Inc.

K-Number K781706

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