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

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    Drakon and Sequre Microcatheters

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    16PW - Cal OSHA

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588025971·16PW - Cal OSHA

    TWINKY STAR

    FDA 510(k)
    FDA Class 2 ·Dental

    Fundus Camera

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·March 16, 2016

    ECLIPSE TRUNION 47MM, SLOTTED, TPS CAP

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code QHQ·August 25, 2021

    ARTHREX ECLIPSE HUMERAL HEAD, 47/20

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code QHQ·August 25, 2021

    UNK

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code KWS·August 24, 2021

    UNIVERSAL GLENOID - INLAY LARGE PLUS

    FDA Adverse Event
    Malfunction ·ARTHREX, INC.·Product code PHX·August 25, 2021

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC.·Product code KDI·October 15, 2008

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 2, 2013

    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    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 MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

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

    Model Number L211 PROPONENT DR SL MRI Pacemaker

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

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

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