BEUDAMED
    12 results · 30ms · Sources: EU EUDAMED, US FDA

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    AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON

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

    PILLING

    FDA UDI
    TELEFLEX INCORPORATED·24026704509168·

    Fifty50 Sport

    FDA UDI
    i-SENS, Inc.·00892896000260·Fifty50 Sport Blood Glucose Monitoring System 2.0

    FILM DIGITZER, MODEL 2908 MAMMO PRO

    FDA 510(k)
    FDA Class 2 ·Radiology

    SAFIRE

    FDA 510(k)
    FDA Class 2 ·Radiology

    ZOLL IVTM THERMOGARD XP

    FDA Adverse Event
    Malfunction ·ZOLL CIRCULATION·Product code NCX·February 23, 2022

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·July 28, 2017

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·July 28, 2017

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code MTA·June 11, 2013

    ALTRX +4 NEUT 36IDX52OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code LPH·June 10, 2011

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·September 10, 2008

    Dressing, Knee L/XL, P/N 04708 Product Usage: These products are sterile dressings used as an insulation barrier between the Polar Care cold therapy pad and the skin. Sterile dressings are typically applied in a non-sterile environment after post-op and on occasion may be applied in a sterile environment. Breg has determined that a small percentage (approximately 0.22%) of these products may have been sent with unsealed pouches by the contract manufacturer. Customers will be contacted and instructed to inspect their inventory for any product with unsealed pouches and discard them.

    FDA Enforcement
    Class II ·Terminated·Breg Inc·May 10, 2017