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

DTB 1979-09-04

MODELS UL-804 AND BL-801 UNIPOLAR LEADS

Applicant Pacesetter Systems

K-Number K791552

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GKZ 1979-09-04

HEMATRAK ABNORMAL RECOGNITION

Applicant Geometric Data, Div. Smithkline Corp.

K-Number K791041

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HGM 1979-09-04

FETASONDE UTERINE ACTIVITY MONITOR

Applicant Roche Medical Electronics, Inc.

K-Number K791038

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KSB 1979-09-04

FLU VEN TR-1

Applicant Venospital, Inc.

K-Number K791131

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LBI 1979-09-04

BILI-DOSIMETER

Applicant Olympic Medical Corp.

K-Number K791114

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N/A 1979-09-04

AXIOM GASTRO SUMP DRAIN

Applicant Axiom Medical, Inc.

K-Number K791509

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JSC 1979-09-04

FLUID THIOGLYCOLLATE MEDIUM

Applicant Isle Media and Sterile Products, Inc.

K-Number K791478

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JSI 1979-09-04

HEKTOEN ENTERIC AGAR

Applicant Isle Media and Sterile Products, Inc.

K-Number K791475

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BZA 1979-09-04

SURELOC EXTERNAL CONNECTOR

Applicant Polamedco, Inc.

K-Number K791532

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GHH 1979-09-04

FIBRO-TEC TEST KIT

Applicant Calbiochem-Behring Corp.

K-Number K791358

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DXY 1979-09-04

IMPLANTABLE PULSE GENERATOR PACEMAKER

Applicant Intermedics, Inc.

K-Number K791417

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JLW 1979-09-04

TSH RIA KIT

Applicant Antibodies, Inc.

K-Number K791217

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