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

DXY 1978-12-22

LITHICRON F PROGRAMMABLE PULSE GEN

Applicant Medcor, Inc.

K-Number K780430

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DTB 1978-12-21

PACING LEAD MODEL BUS 860, BUS 890

Applicant R.E. Brown Co., Inc.

K-Number K781624

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DXY 1978-12-21

PULSTRON MODEL 100

Applicant Micro-Rel

K-Number K781835

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CBK 1978-12-21

VENTILATOR, INFANT MODEL 100

Applicant Healthdyne, Inc.

K-Number K781926

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DXH 1978-12-21

TRANSMITTER, TR-1 ECG

Applicant Burdick Corp.

K-Number K782059

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CBK 1978-12-21

VENTILATOR, MODEL AVA-1, ADULT

Applicant Rule Medical Instruments, Inc.

K-Number K782074

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GEI 1978-12-20

ELECTROSURGICAL UNIT 3001-3009

Applicant Neomed Corp.

K-Number K781810

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KSX 1978-12-20

BLOOD GROUP SUBSTANCE A,B

Applicant North American Biologicals, Inc.

K-Number K781896

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KDI 1978-12-20

CORTRAL I

Applicant Hospal Medical Corp.

K-Number K780527

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JQK 1978-12-20

CLEARING SOLUTION #ECA01976

Applicant Electrophoresis Corp. of America

K-Number K781898

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CDW 1978-12-20

SERUM, BLOOD UREA NITIOGEN

Applicant Fisher Scientific Co., LLC

K-Number K781885

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KEA 1978-12-20

EXTUBE

Applicant Analytichem International, Inc.

K-Number K781728

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