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 1979-03-21

CARDIOPHONE

Applicant North American Motronic

K-Number K781973

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JBP 1979-03-21

ACTIVATOR

Applicant Tri-Med, Inc.

K-Number K790346

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DXY 1979-03-20

MICROLITH MODELS 505;605;507;607;703;803

Applicant Cardiac Pacemakers, Inc.

K-Number K790432

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ESD 1979-03-19

MODEL 337E HEARING AID

Applicant Telex Communications, Inc.

K-Number K790412

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DTD 1979-03-19

IMPLANTABLE HEART LEAD EXTENDER

Applicant Arco Medical Products Co.

K-Number K790468

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CAI 1979-03-19

MODIFIED JACKSON-REES CIRCUIT

Applicant Vital Signs, Inc.

K-Number K790214

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KXT 1979-03-19

EMIT AUTO DIGOXIN ASSAY

Applicant Syva Co.

K-Number K790303

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DXY 1979-03-19

PACEMAKER, OVALITH-D CARDIAC

Applicant Caratomic

K-Number K790566

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KTB 1979-03-19

ELECTROAPPLICATOR MODEL C-1

Applicant Mcg, Inc.

K-Number K790205

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JXR 1979-03-19

AUTOSAMPLER, MODEL AS-40

Applicant The Perkin-Elmer Corp.

K-Number K790117

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BYG 1979-03-16

OXYGEN MASK, ADULT VINYL

Applicant Airlife, Inc.

K-Number K790166

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DRG 1979-03-16

TELEMETRY, BIOMEDICAL

Applicant Lkc Technologies, Inc.

K-Number K790109

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