BEUDAMED
    12 results · 36ms · Sources: EU EUDAMED, US FDA

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    GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1199

    FDA 510(k)
    FDA Class 1 ·Microbiology

    DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T

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

    PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 17, 2025

    DREAMSTATION CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·February 28, 2022

    HEART START XL

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·March 28, 2013

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·April 19, 2011

    RADIESSE DERMAL FILLER

    FDA Adverse Event
    Injury ·BIOFORM MEDICAL,·Product code LMH·June 19, 2008

    ZIMMER M/L TAPER FEMORAL STEM

    FDA Adverse Event
    Injury ·ZIMMER INC·Product code LZO·February 17, 2016

    KINECTIV MODULAR NECK

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code KWA·May 26, 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

    CADD¿- Solis Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015