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

KYT 1978-09-07

PENLIGHTS

Applicant Abco Dealers, Inc.

K-Number K781228

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GYA 1978-09-07

ELECTRODE IMPEDANCE TESTER-MODEL 500

Applicant Life-Tech Instruments, Inc.

K-Number K781475

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HGM 1978-09-07

MODEL 80100A, PATIENT DATA MEMORY

Applicant Hewlett-Packard Co.

K-Number K781360

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DSK 1978-09-07

DINAMAP MODEL 848

Applicant Applied Medical Research

K-Number K781064

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EWO 1978-09-07

PREAMPLIFIER MODELS 8101PI & 8102PI

Applicant Life-Tech Instruments, Inc.

K-Number K781474

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JAK 1978-09-07

ELECTRIC CT/T OPERATOR DISPLAY CONSOLE

Applicant General Electric Co.

K-Number K781431

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LCI 1978-09-01

SYSTEM 6000 AUTOMATED RIA ANALYZER

Applicant Beckman Instruments, Inc.

K-Number K780886

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N/A 1978-09-01

BJORK-SHILEY CARDIAC HEART VALVE

Applicant Shiley, Inc.

K-Number K780772

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KPB 1978-09-01

MYCOPLASMA HYORHINIS (BTS-7)

Applicant Flow Laboratories, Inc.

K-Number K781390

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ELW 1978-08-31

REPROSIL

Applicant Dentsply Intl.

K-Number K781151

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DJC 1978-08-31

KIDNEY, ARTIFICIAL, C-DAK 1.5

Applicant Cordis Corp.

K-Number K781238

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JSX 1978-08-31

MICROCULT-GC CULTURE TEST

Applicant Miles Laboratories, Inc.

K-Number K781108

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