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

GFO 1978-08-10

PLASMA COAGULATION CONT., ABNORMAL

Applicant Ortho Diagnostics, Inc.

K-Number K781104

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CEF 1978-08-10

ECA BUFFER PH 8.8

Applicant Electrophoresis Corp. of America

K-Number K781118

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KZA 1978-08-10

E-Z-JECTOR

Applicant Harco Products

K-Number K780883

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FLK 1978-08-10

THERMOMETER, EXACTA TEMP

Applicant S.M.B. Celsius Co., Inc.

K-Number K781106

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KDQ 1978-08-10

SUCTION CANISTER

Applicant Abco Dealers, Inc.

K-Number K781279

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FLL 1978-08-10

THERMOMETER, MODEL 49TA

Applicant Yellow Springs Instrument Co., Inc.

K-Number K781312

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GAD 1978-08-10

ULTRASOUND IMAGING SYSTEM

Applicant Boehringer Mannheim Corp.

K-Number K780993

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JBQ 1978-08-10

ANTITHROMBIN III SERUM, ANTI-HUMAN

Applicant Icl Scientific

K-Number K781026

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FPA 1978-08-10

INFUSION SET W/ INJECTION SITE, 23D-W

Applicant Venospital, Inc.

K-Number K781187

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KTS 1978-08-10

SECOND ANTIBODY

Applicant Pcl-Ria, Inc.

K-Number K781070

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FMP 1978-08-10

FOAM COMFORT RINGS

Applicant Fibre Formations, Inc.

K-Number K781246

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FRN 1978-08-10

INFUSION PUMP, PEDIATRIC MODEL 301

Applicant Imed Corp.

K-Number K781171

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