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

EKZ 1983-05-16

DIFF 4 SYSTEM

Applicant Coulter Electronics, Inc.

K-Number K830441

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GEC 1983-05-16

MEDICAL PRODUCTS FOAM DOUBLE SCRUB #450

Applicant Ballard Medical Products

K-Number K831226

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HLX 1983-05-16

LED GOGGLES

Applicant Cadwell Laboratories, Inc.

K-Number K831231

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JKA 1983-05-16

EZEE FILTER/SEPARATOR

Applicant The Kendall Company Div. of Tyco Healthcare Group

K-Number K831081

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JST 1983-05-16

STREPTOCOCUS ID PLATE

Applicant Granite Diagnostics, Inc.

K-Number K831349

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GTQ 1983-05-16

TESTCORP ASO

Applicant Catheter Technology Corp.

K-Number K831363

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HQC 1983-05-16

OCUCARE PACK

Applicant Ocular Innovations, Inc.

K-Number K830902

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ITQ 1983-05-16

BRACE C.T.

Applicant Innovation Sports, Inc.

K-Number K831310

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ILQ 1983-05-16

APELLO, PERSONAL HEALTH SUPPORT SYS.

Applicant Almicro Electronics, Inc.

K-Number K831093

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JDI 1983-05-16

LUS ACETABULAR COMPONENT

Applicant Biomet, Inc.

K-Number K830209

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LES 1983-05-16

STRATUS PHENYTOIN FLUOROMETRIC ENZYME

Applicant American Dade

K-Number K831154

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JBX 1983-05-16

PLATELET AGGREGOMETER

Applicant Chrono-Log Corp.

K-Number K830749

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