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

JBD 1980-04-29

A,SA2 LYOPHILIZED HEMO CONTROL

Applicant Helena Laboratories

K-Number K800853

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DIF 1980-04-29

CARDIACS II TOXICOLOGY CONTROL

Applicant Utak Laboratories, Inc.

K-Number K800884

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DQO 1980-04-29

EXTENSION LINE

Applicant Norton Performance Plastics Corp.

K-Number K800622

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EKN 1980-04-29

PREMIER ABSORBENT POINTS

Applicant Premier Dental Products Co.

K-Number K800827

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EHY 1980-04-29

PREMIER TRIPLE TRAY

Applicant Premier Dental Products Co.

K-Number K800900

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JBD 1980-04-29

A,FDA2 LYOPHILIZED HEMO CONTROL

Applicant Helena Laboratories

K-Number K800856

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JQG 1980-04-29

FERRO-QUANT TM FE 59 TEST KIT

Applicant Mallinckrodt Critical Care

K-Number K800868

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CBT 1980-04-29

OMNISTIK, MQ 501GS

Applicant Marquest Medical Products, Inc.

K-Number K800860

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DIF 1980-04-29

HYPNOTICS PLUS ACETAMINOPHEN TX CONTROL

Applicant Utak Laboratories, Inc.

K-Number K800886

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KZD 1980-04-29

MX820-5 PRESSURE INFUSOR 500CC MX820-10

Applicant Medex, Inc.

K-Number K800560

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EBG 1980-04-29

MYERSON'S SPECIAL CROWN & BRIDGE RESIN

Applicant Myerson Tooth Corp.

K-Number K800828

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BZR 1980-04-29

DRAGER ORMC

Applicant Draeger Medical, Inc.

K-Number K800764

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