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

KME 1980-12-10

FLUFF UNDERPAD TYPE UP1001

Applicant Bio D Corp.

K-Number K802740

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FNG 1980-12-10

JACKSON HYDRO SYSTEM

Applicant S. Jackson, Inc.

K-Number K802780

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CHH 1980-12-10

AMES SERA-PAK CHOLESTEROL REAGENT KIT

Applicant Miles Laboratories, Inc.

K-Number K802743

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FKP 1980-12-10

DIALYSIS CONTROL UNIT-CENTRY 2000

Applicant Cobe Laboratories, Inc.

K-Number K802250

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DXW 1980-12-10

MILLAR MIKRO-TIP CATHETER PHONOTRANS

Applicant Millar Instruments, Inc.

K-Number K802830

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LDQ 1980-12-10

DR. MICHAEL'S FOOT HELPER

Applicant Dr. Michael'S Foot-Care Products

K-Number K802837

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JEC 1980-12-10

ORTHOFIX AXIALEXTERNAL FIXATION SYS.

Applicant Cintor Orthopaedic Div.

K-Number K802814

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CFR 1980-12-10

HEXOKINASE, GLUCOSE

Applicant Beckman Instruments, Inc.

K-Number K802810

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KME 1980-12-10

FLUFF UNDERPAD TYPE UP1002

Applicant Bio D Corp.

K-Number K802730

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JOJ 1980-12-09

CHEMICAL INDICATOR - KEM MED & BIO SURE

Applicant Kem Medical Products Corp.

K-Number K802229

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FRC 1980-12-09

BIOLOGICAL INDICATOR - KEMMED & BIOSURE

Applicant Kem Medical Products Corp.

K-Number K802228

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N/A 1980-12-05

BIOLUMIN. SCREENING FOR BACT. BY ATP A.

Applicant Technology, Inc.

K-Number K803077

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