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

BYD 1982-06-29

ENGSTOM EDITH

Applicant Lkb Instruments, Inc.

K-Number K821365

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CAD 1982-06-29

DRAGER VAPOR 19.1 ANESTHETIC VAPORIZERS

Applicant Draeger Medical, Inc.

K-Number K821650

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FPA 1982-06-29

DISPOSABLE INTRAVENOUS INJECTION SYSTEM

Applicant Medical Systems Research

K-Number K821764

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HQZ 1982-06-29

OPHTHALMIC EYEWEAR

Applicant Nordic Eyewear, Inc.

K-Number K821391

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CBK 1982-06-29

OHIO 7000 ELECTRONIC ANESTHESIA VENTIL.

Applicant Ohio Medical Products

K-Number K821376

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N/A 1982-06-28

IREX SYSTEM II 2D/DOPPLER IMAGING SYSTEM

Applicant Irex Corp.

K-Number K827370

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EQN 1982-06-25

NAGASHIMA LIGHT SOURCE UNIT SL-5

Applicant Kelleher Corp.

K-Number K821709

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CAE 1982-06-25

AIRWAYS

Applicant Seven Harvest Intl. Import & Export

K-Number K820709

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GQL 1982-06-25

HISTOSET IMMUNOPEROFIDASE TISSUE

Applicant Immulok, Inc.

K-Number K821411

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KHQ 1982-06-25

ZETAPHASE T3 UPTAKE DIAGNOSTIC KIT

Applicant Amf Biological and Diagnostics Co.

K-Number K821553

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CBN 1982-06-25

FRASER HARLAKE NITRONOX SCAVENGER

Applicant Fraser Harlake, Inc.

K-Number K821744

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JTR 1982-06-25

BIO-CHECK GRAM STAIN CONTROL

Applicant American Scientific Products

K-Number K821660

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