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

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    ARTHROCARE CAVITY SPINEWAND

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

    PORGES SILICONE PROSTATECTOMY CATHETER, STRAIGHT CYLINDRICAL TIP, DELINOTTE TIP, DUFOUR TIP, OVER THE GUIDE TIP, MODEL

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

    CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    MX40 1.4 GHZ SMART HOPPING

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code DSI·February 27, 2013

    ZMR HIP XL TAPER STEM

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code LPH·March 22, 2011

    ASCENSIA CONTOUR

    FDA Adverse Event
    Injury ·BAYER HEALTHCARE, LLC·Product code NBW·June 20, 2008

    SCREW,FIXATION,BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HWC·July 11, 2016

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DQX·August 30, 2023

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·December 23, 2022

    RADIFOCUS GLIDEWIRE ADVANTAGE

    FDA Adverse Event
    Injury ·TERUMO CORPORATION, ASHITAKA·Product code DQX·March 19, 2025

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC TRACHEOSTOMY TUBE 3.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS35; d) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS40; e) PEDIATRIC TRACHEOSTOMY TUBE 4.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS45; f) PEDIATRIC TRACHEOSTOMY TUBE 5.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS50; g) PEDIATRIC TRACHEOSTOMY TUBE 5.5mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS55

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024

    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