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

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    TRANSLUX POWER BLUE

    FDA 510(k)
    FDA Class 2 ·Dental

    CARTO XP SYSTEM

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER, LTD·Product code DQK·November 30, 2007

    CARTO XP EP NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·August 14, 2008

    SeaSpine

    FDA UDI
    Avalign Technologies, Inc.·00190776149529·POSTERIOR VERTEBRAL BODY PUNCH, 20mm WIDE

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776391409·Posterior Vertebral Body Punch, 20mm Wide

    DIGICAP

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

    MODIFICATION TO LIQUID GLUCOSE (HEXOKINASE) REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    CARTO XP EP NAVIGATION SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER LTD. (HAIFA, ISREAL)·Product code DQK·April 17, 2008

    ZELTIQ COOLMAX (8.0)

    FDA Adverse Event
    Injury ·ZELTIQ AESTHETICS, INC.·Product code OOK·April 4, 2013

    PAGEWRITER TOUCH CARDIOGRAPH

    FDA Adverse Event
    Death ·PHILIPS HEALTHCARE·Product code DPS·March 30, 2011

    ENDOTAK RELIANCE G

    FDA Adverse Event
    Injury ·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·December 19, 2023

    Active Life Little Ones One-Piece Custom Urostomy Pouch 5/16 - 1 inch, 8-25mm; Ostomy pouch and accessories, Product Order Number 020917, Nypro Dominican Republic Inc., ConvaTech, Skillman, NJ 08558

    FDA Recall
    Terminated ·ConvaTec·Product code EXB·February 14, 2008

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·August 3, 2022

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·February 16, 2023

    CARTO® 3 SYSTEM

    FDA Adverse Event
    Malfunction ·BIOSENSE WEBSTER INC·Product code DQK·April 25, 2023

    PKG, ATRAUMATIC FORCEPS, DOUBLE ACTION, P/N 0250080311. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    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