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

JFH 1980-11-12

CBC PAP TEST KIT

Applicant Calbiochem-Behring Corp.

K-Number K802153

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HKO 1980-11-12

OBJECTIVE REFRACTOR

Applicant Zeiss Humphrey System

K-Number K802029

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LOS 1980-11-12

12SSL ECG ANALYSIS PROG.(SCALER LEAD)

Applicant Marquette Electronics, Inc.

K-Number K802369

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KKX 1980-11-12

DISPOSABLE SURGICAL DRAPE

Applicant Texas Medical Products, Inc.

K-Number K802537

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BYI 1980-11-12

HAND PERCUSSOR CUP #65210

Applicant B & F Medical Products, Inc.

K-Number K802646

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FJI 1980-11-12

DISSCAP HOLLOW FIBER DIALYZER

Applicant Hospal Medical Corp.

K-Number K802466

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DSH 1980-11-12

MEDICAL MAGNETIC TAPE RECORDER

Applicant Medical Concepts, Inc.

K-Number K802564

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KSX 1980-11-12

GAMMA LEWIS BLOOD GROUP SUBSTANCE

Applicant Gamma Biologicals, Inc.

K-Number K802533

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CDN 1980-11-12

BUN REAGENT ASTRA 4 & 8 ANALYZERS

Applicant Nobel Scientific Industries, Inc.

K-Number K802518

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KKX 1980-11-12

BOUNDARY SURGICAL DRAPES WITH ADHESIVE

Applicant Procter & Gamble Mfg. Co.

K-Number K802652

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JTO 1980-11-12

X & V FACTOR DISCS

Applicant Oxoid U.S.A., Inc.

K-Number K802502

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EFQ 1980-11-12

MAJOR DRESSING TRAY-MILFORD HOSP.

Applicant American Medical Disposable, Inc.

K-Number K802388

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