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

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    BIOPSY HANDY, MRI BIOPSY HANDY

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    B.BRAUN

    FDA UDI
    B.Braun Avitum AG·04039239040859·ABPM Cuff (medium) (7102771)

    Oticon

    FDA UDI
    Oticon A/S·05707131167255·AGPR, ITC P DIR R BE AGIL PRO

    Tasso Mini

    FDA UDI
    Tasso Inc.·00850038691134·

    TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    RELINE-IT MODEL RELINE-IT

    FDA 510(k)
    FDA Class 2 ·Dental

    BILATERAL DOUBLE BALLOON SET

    FDA Adverse Event
    Malfunction ·PAJUNK GMBH MEDIZINTECHNOLOGIE·Product code KOG·December 7, 2006

    SELEX/MAGNUM MODULAR HEAD 40MM +6

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·May 9, 2013

    ONETOUCHPING GLUCOSEMGMTSYSTEM

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

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 23, 2011

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA S.R.L.·Product code DTN·February 22, 2017

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·March 24, 2016

    BMR1900 PH.I.S.I.O VENOUS RESERVOIR BAG

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTN·July 25, 2018

    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

    Exactech Equinoxe CAGE GLENOID, CEMENTED, beta curvature, Mates with: a) 47, 50, 53 head, Medium, Item Number 314-13-13, b) 47, 50, 53 head, Large, Item Number 314-13-14, c) 47, 50, 53 head, Extra Large, Item Number 314-13-15; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021

    Model Number L101, ESSENTIO DR SL Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Accolade pacemaker, Models: a) L300 b) L301 c) L310 d) L311 e) L321 f) L331

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021