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

HTR 1978-05-16

MICRO RASPS

Applicant Amsco Co.

K-Number K780771

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CDT 1978-05-12

DATA-ZYME TRIGLYCERIDE PROCEDURE

Applicant Data Medical Associates, Inc.

K-Number K780379

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EJE 1978-05-12

HYGIENIC RUBBER DAM FRAME

Applicant Hygienic Dental Mfg., Co., The

K-Number K780746

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HCC 1978-05-12

RELAX-A-TONE

Applicant Bio Response

K-Number K780436

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BTR 1978-05-12

FOME-CUF PVC

Applicant Bivona Medical Technologies

K-Number K780583

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JRW 1978-05-12

CULTURE SWAB

Applicant Royal Scientific, Inc.

K-Number K780713

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ITI 1978-05-12

POWER STRIDER

Applicant Seidel Manufacturing, Inc.

K-Number K780402

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CIT 1978-05-12

AST(GOT) UNI-UV, SGOT

Applicant Sclavo, Inc.

K-Number K780463

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KWA 1978-05-12

TOTAL HIP, LORD MADREPORIC

Applicant Howmedica Corp.

K-Number K780330

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EEF 1978-05-12

BRINKER TISSUE RETRACTORS

Applicant Hygienic Dental Mfg., Co., The

K-Number K780744

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ESD 1978-05-12

HEARING AID BATTERY CHARGER

Applicant Cahill Enterprises, Inc.

K-Number K780694

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N/A 1978-05-12

IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST

Applicant Clinical Assays, Inc.

K-Number K780709

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