BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    BodyGuardian Remote Monitoring System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HHM

    FDA UDI
    Oticon A/S·05707131280121·H110, DESIGNRITE 10 WL MIBU HHM

    GRAFTON DBM

    FDA 510(k)
    FDA Class 2 ·Dental

    COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 3, 2021

    GRAFTON DBM

    FDA Adverse Event
    Injury ·MEDTRONIC EATONTOWN·Product code NUN·July 6, 2019

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 6, 2013

    UNKNOWN DEPUY 32X56 LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JDI·June 30, 2011

    VERSACARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·September 9, 2008

    Medical Linear Accelerator

    FDA Enforcement
    Class II ·Terminated·Elekta, Inc.·September 14, 2016

    Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025