BEUDAMED
    16 results · 21ms · Sources: EU EUDAMED, US FDA

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    MIS Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    Sonic

    FDA UDI
    Sonic Innovations, Inc.·05711583032993·ET20, KIT 312 NFM 85 PB L BE ENCHANT 20

    GAUNYING INFRARED LAMP

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215

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

    ONE TOUCH ULTRA

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CFR·March 11, 2002

    TUBE, GASTROINTESTINAL (AND ACCESS)

    FDA Adverse Event
    Malfunction ·C. R. BARD INC. (BASD)·Product code KNT·November 21, 2008

    TUBE, GASTROINTESTINAL (AND ACCESS)

    FDA Adverse Event
    Malfunction ·C. R. BARD INC. (BASD)·Product code KNT·October 24, 2008

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 2, 2024

    TENDRIL ST

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code NVN·January 13, 2014

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 4, 2011

    ACCU-CHEK SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·June 27, 2013

    PROAQT SENSOR

    FDA Adverse Event
    Malfunction ·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025

    PROAQT SENSOR

    FDA Adverse Event
    Malfunction ·PULSION MEDICAL SYSTEMS SE·Product code DXG·August 18, 2025

    MultiDiagnostic-Eleva with Flat Detector 708038 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

    Mutlidiagnost-Eleva with Flat Detector Eleva with Flat Detector 708037 As a multifunctional universal imaging application system, General RJF, Fluoroscopy, Radiography and Angiography can be Performed along with more specialized interventional applications on human patients.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Nederlands·May 9, 2018

    Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

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