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

BYX 1979-09-26

CORRUGATED FLEXIBLE POLYETHYLENE & EVA

Applicant Airlife, Inc.

K-Number K791821

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BWF 1979-09-26

AIR INCENTIVE SPIROMETER

Applicant Airlife, Inc.

K-Number K791819

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DXY 1979-09-26

EDWARDS PACEMAKER 30 UNIPOLAR GENERATOR

Applicant Edwards Pacemaker Systems

K-Number K791751

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BZO 1979-09-26

Y & ELBOW W/WO PORTS

Applicant Airlife, Inc.

K-Number K791856

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GSH 1979-09-24

AGGLUTINOTEST-LISTERIA

Applicant Volu Sol Medical Industries

K-Number K791459

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FMI 1979-09-24

HYPERDERMIC NEEDLE WITH SENSOR #514

Applicant Medtech Intl., Inc.

K-Number K791462

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GOX 1979-09-24

AGGLUTINOTEST-PERTUSSIS

Applicant Volu Sol Medical Industries

K-Number K791454

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FEA 1979-09-24

AO TEACHING ATTACHMENT, MODEL TA-1

Applicant American Optical Corp.

K-Number K791635

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GMT 1979-09-24

AGGLUTINOTEST-SYPHILIS

Applicant Volu Sol Medical Industries

K-Number K791457

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GQM 1979-09-24

HERPES EIA TEST KIT

Applicant Microbiological Assoc.

K-Number K791397

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FMP 1979-09-24

HEEL/ELBOW PROTECTORS

Applicant Fibre Formations, Inc.

K-Number K791709

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JLW 1979-09-24

ORTHO TSH RIA KIT

Applicant Ortho Diagnostics, Inc.

K-Number K791301

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