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

GKL 1978-05-19

MICROCELL COUNTER MODEL CC-108

Applicant Toa Medical Electronics USA, Inc.

K-Number K780224

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DTB 1978-05-19

SUTURELESS MYOCARDIAL PACING LEAD

Applicant Medtronic Vascular

K-Number K780446

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KRC 1978-05-19

ELECTRODE TESTER

Applicant Mg Medical Electronics

K-Number K780501

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CFR 1978-05-19

ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEM

Applicant Harleco

K-Number K780515

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JIX 1978-05-19

COMP. CLIN. CHEM. REF. SERUM-BENCHMARK

Applicant Beckman Instruments, Inc.

K-Number K780553

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CAE 1978-05-19

AIRWAYS

Applicant Abco Dealers, Inc.

K-Number K780601

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CHH 1978-05-19

REAGENT SET HDL CHOLESTEROL

Applicant Boehringer Mannheim Corp.

K-Number K780635

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DRT 1978-05-19

CARDIAC MINISCOPE & MINIGRAPH

Applicant Arco Medical Products Co.

K-Number K780297

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DRT 1978-05-19

CSS-60 DIGITAL HEART RATE METER

Applicant Burdick Corp.

K-Number K780702

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DPS 1978-05-19

CARDIAC MINIGRAPH

Applicant Arco Medical Products Co.

K-Number K780307

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CHH 1978-05-19

ULTRACHEM ENZYMATIC CHOLESTEROL 65025

Applicant Harleco

K-Number K780523

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FJG 1978-05-19

RP-510/RP-514 PARALLEL PLATE DIALYZERS

Applicant Hospal Medical Corp.

K-Number K780427

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