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

DXY 1977-04-26

GENERATOR, PULSE, IMPLANTABLE

Applicant Med Telectronics , Ltd.

K-Number K770661

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KHM 1977-04-26

REAGENT, AMYLASE LIPASE

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K-Number K770400

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GCJ 1977-04-26

TROCAR SLEEVE SYSTEM 4MM TO 3.4MM

Applicant Richard Wolf Medical Instruments Corp.

K-Number K770712

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GZI 1977-04-26

STIMULATOR, MUSCLE, MODEL 107

Applicant Jaytronics, Inc.

K-Number K770725

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DYB 1977-04-26

CATHETER,PERCUTANEOUS INTRODUC. & SHEATH

Applicant Usci, Div. C.R. Bard, Inc.

K-Number K770561

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HRX 1977-04-26

NEEDLE, SPRAY

Applicant Richard Wolf Medical Instruments Corp.

K-Number K770710

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HGM 1977-04-26

MONITOR, FETAL, NO. L04-1100

Applicant Brattle Instrument Corp.

K-Number K770692

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DXY 1977-04-26

GENERATOR, PULSE, UNIPOLAR, MODEL #504

Applicant Cardiac Pacemakers, Inc.

K-Number K770716

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DTN 1977-04-26

BLOOD RESERVOIR

Applicant Delta Medical Industries

K-Number K770546

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JTW 1977-04-26

BOTTLE, BLOOD CULTURE, BI-PHASIC

Applicant Gibco Laboratories Life Technologies, Inc.

K-Number K770683

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DXY 1977-04-26

GENERATOR, PULSE, CARDIAC 2LU

Applicant Edwards Pacemaker Systems

K-Number K770657

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KRI 1977-04-26

VALVE, PRESSURE RELIEF, BLOOD OXYGENATOR

Applicant Scimed Life Systems, Inc.

K-Number K770681

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