BEUDAMED
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    ARK EDDP Assay

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    APEX MODULAR ACCTABULAR CUP (NOW NAMED APEX INTERFACE ACETABULAR SYSTEM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DEXCOM ONE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·July 26, 2024

    STEM: AMISTEM H HA COATED LAT STEM SIZE 0

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code LZO·October 3, 2019

    FEMORAL NAIL, A/R T2 FEMUR ? 10X380MM

    FDA Adverse Event
    Injury ·STRYKER TRAUMA GMBH·Product code HSB·August 3, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code OYC·June 21, 2013

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 8, 2011

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·October 17, 2014

    TDC VELOCE", 23G Two Dimensional Cutter - 20k CPM; Article Numbers: 9268.VIT23, 9311.23G01, 9311.23G02, 9311.23K01, 9311.23K02, 9311.23K03, 9623.G0201, 9623.G0202, 9623.K0201, 9311.23G01-00;

    FDA Enforcement
    Class II ·Ongoing·D.O.R.C. Dutch Opthalmic Research Center Intl B.V.·June 17, 2026

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014