BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    eufy Wearable Breast Pump S1 (T8D02); eufy Wearable Breast Pump E10 (T8D03)

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Vilex Guidewire

    FDA UDI
    VILEX IN TENNESSEE, INC.·00841731120731·Guidewire 2.0x250mm Drill Tip

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180137899·5 MM DIA., 32 CM SPOON WITH TEETH, STAINLESS ST...

    Bradshaw Medical Inc.

    FDA UDI
    Bradshaw Medical, Inc.·00810019931017·BIT, HEX FEMALE 1/8 1/4 SQ

    Kleiner KG2 system

    FDA UDI
    Baat Medical Products B.V.·08720246782844·Trial

    xPORT S Lens Fragmentation System

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BD POSIFLOW POSITIVE DISPLACEMENT VALVE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 28, 2024

    OT VERIO2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·November 7, 2015

    I-STAT 6+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·December 8, 2020

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL MANUFACTURING CORPORATION·Product code MVK·November 6, 2014

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·September 15, 2011

    GRANUFLO

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·July 23, 2013

    SHOULDER SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·December 27, 2024

    15 g R.K. Epidural Needle (TW), Catalog #/REF #100-1415 Intended for the epidural placement, directly or through an epidural catheter, of anesthetic agents to elicit regional anesthesia

    FDA Recall
    Terminated ·Epimed International, Inc.·Product code BSP·April 22, 2016

    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

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024