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

JSI 1982-07-06

CNA/VAGINALIS AGAR

Applicant Hardy Media

K-Number K821608

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EJY 1982-07-06

BEACH SURGICAL PLIERS NON-HOOK

Applicant Pacific Dental Corp.

K-Number K821787

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KQO 1982-07-06

CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST

Applicant Miles Laboratories, Inc.

K-Number K821738

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JSJ 1982-07-06

MYCOBIOTIC AGAR

Applicant Hardy Media

K-Number K821603

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DTE 1982-07-06

EXTERNAL PULSE GENERATOR - EV4542

Applicant American Pacemaker Corp.

K-Number K821791

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JSC 1982-07-06

TRYPTIC SOY AGAR

Applicant Hardy Media

K-Number K821601

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EMN 1982-07-06

BEACH SCALERS

Applicant Pacific Dental Corp.

K-Number K821786

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FOZ 1982-07-02

LEONARD/NORTON HYPERALIMENTATION CATHET.

Applicant Norton Performance Plastics Corp.

K-Number K821679

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FYA 1982-07-02

BOUNDARY PROCESS CHANGE

Applicant The Buckeye Cellulose Corp.

K-Number K821564

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FPA 1982-07-02

AS 700 SERIES INFUSION PUMP ADMIN.

Applicant Narco Scientific

K-Number K821377

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GKL 1982-07-02

SYSMEX CC-800

Applicant Sysmex/Toa Medical Electronics, Inc.

K-Number K821575

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N/A 1982-07-02

DIAGNOSTICS HDL CHOLESTEROL PRECIPITANT

Applicant Boehringer Mannheim Corp.

K-Number K821852

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