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

KQG 1982-07-22

ELVI BICLOT 816

Applicant Volu Sol Medical Industries

K-Number K812906

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CKA 1982-07-22

SGPT-UV REAGENT SET

Applicant Omega Medical Electronics

K-Number K821206

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N/A 1982-07-22

SUNTANNING BOOTH

Applicant Carribean Connection

K-Number K827666

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HYI 1982-07-22

GRAMSTAIN SET

Applicant Granite Diagnostics, Inc.

K-Number K821977

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KPA 1982-07-22

MI DAS 1000 AUTOMATIC SLIDE STAINER

Applicant Innovative Medical Systems, Inc.

K-Number K821830

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N/A 1982-07-22

OCULAR BIOMETER 4000

Applicant Radionics Medical, Inc.

K-Number K827035

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CDW 1982-07-22

UREA NITROGEN REAGENT SET

Applicant Omega Medical Electronics

K-Number K821212

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JJT 1982-07-22

TITAN GEL CPK/LDH ISOENZYME CONTROL

Applicant Helena Laboratories

K-Number K821981

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LFJ 1982-07-22

MCPARLAND SCALP VEIN CATHETER

Applicant Renal Systems, Inc.

K-Number K821001

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N/A 1982-07-22

MODEL 712 MICROMANIPULATOR

Applicant Laser Industries , Ltd.

K-Number K827607

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HRX 1982-07-22

I.M. ARTHROSCOPE

Applicant Instrument Makar, Inc.

K-Number K821847

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KNX 1982-07-22

U-200 BAG

Applicant Medical Technologies of Georgia

K-Number K821854

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