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

DRS 1982-04-14

FLEX-E1 ECG ELECTRODE

Applicant Conmedcorp

K-Number K820579

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CEP 1982-04-14

MR1 LUTROPIN RIA KIT

Applicant Microanalytic Research, Inc.

K-Number K820741

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N/A 1982-04-14

SURGICAL INSTRUMENTS

Applicant Intl. Needle, Inc.

K-Number K820682

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LKH 1982-04-14

HISTOSET IMMUNOPEROXIDASE TISSURE KIT

Applicant Immulok, Inc.

K-Number K820390

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GBO 1982-04-13

PERCUTANEOUS NEPHROSTOMY SET

Applicant Van-Tec, Inc.

K-Number K820867

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JHY 1982-04-12

CREATINE KINASE-MB KIT

Applicant Calbiochem-Behring Corp.

K-Number K820812

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DXY 1982-04-09

IMPLANTABLE, MULTIPROGRAMMABLE

Applicant Biotronik Sales, Inc.

K-Number K820774

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DTB 1982-04-09

BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60

Applicant Siemens Elema AB

K-Number K820767

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HCB 1982-04-09

ELECTROSTIMULI AVERSION MACHINE

Applicant Michael R. Kiss

K-Number K820622

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CEP 1982-04-09

AMERLEX LH RIA KIT (CODE IM2081)

Applicant Amersham Corp.

K-Number K820753

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ESD 1982-04-09

RIONET HEARING AID HA-57

Applicant Rion Acoustic Instruments, Inc.

K-Number K820656

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HLZ 1982-04-09

GOLD FOIL ERG ELECTRODES

Applicant Cadwell Laboratories, Inc.

K-Number K820254

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