BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    MONTERIS MEDICAL NEUROBLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 4, 2024

    INERTIA PEDICLE SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STRYKER FLEXIBLE URETEROSCOPE

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

    ENCOMPASS SYNERGY CLAMP (LONG)

    FDA Adverse Event
    Malfunction ·ATRICURE, INC.·Product code OCL·October 5, 2023

    ACCU-CHEK ® AVIVA COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·October 1, 2014

    ALBUSTIX

    FDA Adverse Event
    Other ·KIMBALL ELECTRONICS·Product code CHL·May 13, 2013

    ATTAIN OTW

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 16, 2011

    FUSION 8MM-40CM UNSUPP PERIPHERAL GRAFT

    FDA Adverse Event
    Malfunction ·MAQUET CV·Product code DSY·February 8, 2017

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016