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

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    ZEUS ELISA HSV GG-2 IGG TEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Oticon

    FDA UDI
    Oticon A/S·05707131166159·SAF600SP, BTE DBL DEMO SAFARI 600 SP

    PC TAN

    FDA UDI
    BLV Licht- und Vakuumtechnik GmbH·B5331036030·

    Tasso+ Convenience Kit

    FDA UDI
    Tasso Inc.·00860006434564·Tasso+ convenience kit allows self-collection o...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383561716·Gutta Percha Points is used to root canal filin...

    GUTTA PERCHA POINTS

    FDA UDI
    DiaDent Group International·08806383503051·Gutta Percha Points is used to root canal filin...

    MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    BIO HERADOR SG, BIO HEADER GG, HERADOR S, BIO HERADOR N, HERABOND, HERALOY G, ALBABOND, BIO MAINGOLD SG, MAINGOLD SG, HE

    FDA 510(k)
    FDA Class 2 ·Dental

    PROGAV®

    FDA Adverse Event
    Injury ·CHRISTOPH MIETHKE GMBH & CO. KG·Product code JXG·January 3, 2018

    SYNGO SUITE FOR ONCOLOGY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA, INC.·Product code MUJ·November 9, 2012

    SC-HEART-LUNG-MACHINE

    FDA Adverse Event
    Malfunction ·LIVANOVA DEUTSCHLAND·Product code DTQ·April 26, 2017

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·May 9, 2013

    SUPPORT ARM 177

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code MOD·May 30, 2008

    E1 RINGLOC ACETABULAR LINER 40MM SZ 25

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·May 26, 2011

    AMO PhacoFlex II Model SI40NB, Intraocular Lenses

    FDA Recall
    Terminated ·Allergan Medical Optics Inc·July 2, 2003

    GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological

    FDA Enforcement
    Class II ·Ongoing·GE Healthcare·March 11, 2026

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012

    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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021