BEUDAMED
    15 results · 18ms · Sources: EU EUDAMED, US FDA

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    PORTABLE HDX INTRAORAL X-RAY

    FDA 510(k)
    FDA Class 2 ·Dental

    ULTRAPOWER

    FDA UDI
    Conmed Corporation·10845854000953·1.9MM ULTRAPOWER BUR, ROUND/CYLINDRICAL DIAMOND...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450157282·

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·April 16, 2024

    JOE LUB HELMET CONDOM

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

    BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INNOVA 4100

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·April 4, 2011

    INNOVA 4100

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS·Product code MQB·May 6, 2011

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 29, 2007

    CYBERWAND

    FDA Adverse Event
    Malfunction ·CYBERSONICS, INC.·Product code FEO·March 11, 2013

    HUDSON AQUAPAK W/ 040 ADAPTOR

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CAF·February 8, 2011

    CT EXPRES

    FDA Adverse Event
    Injury ·BRACCO INJENEERING S.A.·Product code IZQ·September 27, 2023

    VS3 Iridium Visionsense Infrared (IR) Fluorescence Miniature Microscope (MMS-IR) Product Number: 174-0012

    FDA Enforcement
    Class II ·Ongoing·Visionsense, Ltd.·November 30, 2022

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012