BEUDAMED
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    Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Sonic

    FDA UDI
    Sbo Hearing A/S·05714464089925·SONIC ENCHANT SE 20 B 105 DG DEMO

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180154063·5 MM DIA., 32 CM, NEEDLE HOLDER, CURVED LEFT TU...

    Capillus 272 Office Pro

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    FDA Adverse Event
    Malfunction ·HEARTWARE, INC·Product code DSQ·November 14, 2014

    ASR UNI FEMORAL IMPL SIZE 55

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·September 16, 2011

    PULSE GEN MODEL 102

    FDA Adverse Event
    Injury ·CYBERONICS, INC.·Product code LYJ·July 26, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013