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

IKN 1981-10-13

TECA #TE 8

Applicant Teca, Inc.

K-Number K812715

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KRJ 1981-10-13

PRE-BYPASS FILTER

Applicant Gelman Sciences, Inc.

K-Number K812539

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HRH 1981-10-13

PEARCE CORNEAL TREPHINE

Applicant Visitec Co.

K-Number K812723

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JHI 1981-10-13

TANDEM QUALITATIVE HCG KIT

Applicant Hybritech, Inc.

K-Number K812461

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DRS 1981-10-13

TRANSDUCER DOME

Applicant Biomeal Corp.

K-Number K812530

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CAW 1981-10-13

LIF-O-GEN #3000 OXYGEN CONCENTRATOR

Applicant Lif-O-Gen, Inc.

K-Number K812693

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JAK 1981-10-13

4001 CT SCANNER

Applicant Omnimedical

K-Number K812393

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IYN 1981-10-13

SECTORTAC

Applicant Echo Laboratories, Inc.

K-Number K812606

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N/A 1981-10-13

DISK

Applicant American Heartline, Inc.

K-Number K812695

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DRT 1981-10-13

INFANT CARIDAC MONITOR

Applicant Electromed Intl., Ltd.

K-Number K812674

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FOH 1981-10-13

NEONATE FLEXFLOAT

Applicant Pharmaquest Corp.

K-Number K812683

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HET 1981-10-13

LAPAROSCOPE

Applicant Reznik Instruments

K-Number K812206

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