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

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    IM BAND

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SimplyGo Mini

    FDA UDI
    Respironics, Inc.·00606959032385·SimplyGo Mini Device, USA

    Adapter, Rubber, 1 3/8 TO 7/8

    FDA UDI
    A-M SYSTEMS, LLC·00817081022865·Adapter, Tube, Blue Autoclavable Thermoplastic ...

    N/A

    FDA UDI
    HANS RUDOLPH, INC.·00874750003860·75 V2 LG 22OD STRAIGHT NO HG

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1106000·Tray, Base, 6", Arcamed

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702867985·ELVAREX 1/KNEE HIGH/SLANT-OPEN TOE/SLIP FORM WI...

    JOBST Elvarex

    FDA UDI
    BSN-Jobst GmbH·04019702257502·Elvarex 2/Thigh High/Slant, Open Toe, E-Version...

    COLLAGEN DENTAL MAMBRANE - PORCINE TYPE I COLLAGEN

    FDA 510(k)
    FDA Class 2 ·Dental

    PORTABLE X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523142781·L PS Cemented Femoral Component Sz 6

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523123988·CR Femoral Trial Sz 6 L

    Kyocera Medical Technologies, Inc.

    FDA UDI
    KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523147984·PS Femoral Trial Sz 6 L

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 9, 2025

    RESTORE RECHARGEABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·February 18, 2009

    ARCHITECT ANTI-HCV

    FDA Adverse Event
    Malfunction ·ABBOTT GERMANY·Product code MZO·May 15, 2013

    HOMECHOICE PRO

    FDA Adverse Event
    Death ·BAXTER HEALTHCARE - LARGO·Product code FKX·September 24, 2014

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE DUPLICATE·Product code MKJ·May 24, 2011

    SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600

    FDA Recall
    Open, Classified ·Philips Respironics, Inc.·Product code CAW·October 7, 2025

    SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected battery kits are sold as accessories for the SimplyGo Mini: SimplyGo Mini Portable Oxygen Concentrator Product code: 1113600

    FDA Enforcement
    Class II ·Ongoing·Philips Respironics, Inc.·November 19, 2025

    EMBLEM S-ICD Model A209

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021