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

JIX 1978-12-04

SERACON-SRII

Applicant Bhp Diagnostix, Inc.

K-Number K781758

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FZZ 1978-12-04

PEN, MARK-3 SKIN MARKING FOUNTAIN

Applicant Omega Mark-3 Pen Corp.

K-Number K781694

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JBQ 1978-12-04

ASSAY, CHROMOGENIC ANTITHROMBIN III

Applicant Ortho Diagnostics, Inc.

K-Number K781860

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IZL 1978-12-04

MOBILE X-RAY UNIT

Applicant General X-Ray, Inc.

K-Number K781976

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DRG 1978-12-04

TELEMETRY SYSTEM, BIOTEL 300

Applicant Spacelabs, Inc.

K-Number K781836

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IYT 1978-12-04

DISPENSOR, XENON GAS

Applicant Diagnostic Isotapes, Inc.

K-Number K781933

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DTB 1978-12-04

ENDOCARDIAL BIPOLAR LEAD

Applicant American Technology, Inc.

K-Number K781456

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DYN 1978-12-04

SURGICAL ASPIRATOR TIPS

Applicant Henry Schein, Inc.

K-Number K781592

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DTB 1978-12-04

UNIPOPLAR ENDOCARDIAL LEADS

Applicant American Technology, Inc.

K-Number K781326

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EAP 1978-12-04

GE-700 INTRA ORAL X-RAY SYSTEM

Applicant General Electric Co.

K-Number K781630

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IZL 1978-12-04

MOBILE CARRIER

Applicant General X-Ray, Inc.

K-Number K781975

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DXY 1978-12-04

OVALITH 10BP

Applicant Coratomic, Inc.

K-Number K781377

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