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

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    Microwave Ablation System (BD-GT)

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

    NA

    FDA UDI
    DEPUY MITEK, LLC·10886705011063·LIGAMENT GRAFT PASSER/PROTECTOR 7.5mm

    BINDAZYME HUMAN ANTI-PHOSPHATIDYLSERINE IGA, IGG AND IGM ENZYME IMMUNOASSAY KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM06 SERIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GORE® VIABAHN® ENDOPROSTHESIS WITH PROPATEN BIOACTIVE SURFACE

    FDA Adverse Event
    Injury ·W. L. GORE & ASSOCIATES, INC.·Product code NIP·May 15, 2023

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·February 11, 2022

    LAP-BAND ADUSTABLE GASTRIC BANDING SYSTEM

    FDA Adverse Event
    Injury ·COSTA RICA·Product code LTI·November 13, 2008

    DXTEND STAND PE CUP D42 +9MM

    FDA Adverse Event
    Injury ·DEPUY FRANCE S.A.·Product code KWS·August 18, 2011

    PTFE MESH

    FDA Adverse Event
    Injury ·DAVOL INC., SUB C.R. BARD, INC.·Product code FTL·July 8, 2013

    SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567394941, 453567394942, 453567394943, 453567394945, 459801593182. Coils may be included in kits with Mode Numbers: 989603050641, 989603050642.

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