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

DSH 1981-07-10

CASSETTE READER

Applicant American Edwards Laboratories

K-Number K811253

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DXN 1981-07-10

TENSIOMETER

Applicant Vivitek, Inc.

K-Number K811781

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LCD 1981-07-10

VIRGO IPA FOR DETECTION OF GENTAMICIN

Applicant Electro-Nucleonics Laboratories, Inc.

K-Number K811744

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DSF 1981-07-10

NOVATRACER RECORDER

Applicant Novametrix Medical Systems, Inc.

K-Number K811453

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HYB 1981-07-10

EOSIN Y

Applicant Surgipath

K-Number K811826

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CDS 1981-07-10

BUN RATE REAGENT

Applicant Chem-Elec, Inc.

K-Number K811193

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DJB 1981-07-10

COAT-A-COUNT GENTAMICIN RIA KIT

Applicant Diagnostic Products Corp.

K-Number K811844

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HIL 1981-07-10

PLAYTEX PROCESS MACHINERY CHANGE

Applicant Playtex, Inc.

K-Number K811386

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DIP 1981-07-10

VIRGO IPA FOR DETECTION OF PHENYTOIN

Applicant Electro-Nucleonics Laboratories, Inc.

K-Number K811745

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DIF 1981-07-10

TDM ANTI-CONVULSANT CONTROL LEVELS I-II

Applicant Environmental Chemical Specialties

K-Number K811811

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KCW 1981-07-10

EPILATOR, MULTIPLE NEEDLE-MODEL EM-20

Applicant Rcx-Western, Inc.

K-Number K811501

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DHY 1981-07-10

LIGHTNING DIALYZER

Applicant Clintox Laboratories, Inc.

K-Number K810871

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