BEUDAMED
    15 results · 23ms · Sources: EU EUDAMED, US FDA

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    AG THERMOGRAPHIC CAMERA, MODEL ATIR-M301

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00860006434571·Tasso+ convenience kit allows self-collection o...

    OrthoMedFlex

    FDA UDI
    ORTHOMEDFLEX LLC·M7161016410·Tray, Tryon II Acetabular System - Upper and Lo...

    PERCLOSE PROGLIDE

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code MGB·January 9, 2025

    INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET)

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

    TAMPONS

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    PERCLOSE¿ PROSTYLE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·January 23, 2025

    6000 CMS IOD

    FDA Adverse Event
    Malfunction ·MOOG DEVICE GROUP·Product code FRN·April 30, 2013

    ANIMAS VIBE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 19, 2014

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 11, 2011

    PERCLOSE¿ PROSTYLE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·April 24, 2024

    ARMADA 14 PTA CATHETER

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code DQY·January 2, 2020

    MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.

    FDA Enforcement
    Class II ·Terminated·Medrad Inc·February 27, 2013

    Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05

    FDA Enforcement
    Class I ·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025