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

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    DIGITAL AMBULATORY ECG (HOLTER) RECORDER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0310040·Probe, 1.5 inch Ball, Lenke, Straight, Black

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0310540·T-Handle, Primal, 1/4 inch Square, Cannulated

    VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA

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

    CRYOCARE SURGICAL SYSTEM

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

    ENDOCARE, CRYOCARE, CRYOPROBE

    FDA Adverse Event
    Malfunction ·HEALTHTRONICS, INC.·Product code GEH·April 2, 2012

    Temporary Total Artificial Heart (TAH-t) with Freedom Driver System REF 595000-001 Product Usage: Freedom Drivers are components of the SynCardia temporary Total Artificial Heart (TAH-t) System, which is indicated for use in transplant-eligible candidates at risk of imminent death from biventricular failure. Freedom Drivers are intended for use in and out of the hospital.

    FDA Enforcement
    Class I ·Terminated·SynCardia Systems Inc.·September 23, 2015

    KNIFW

    FDA Adverse Event
    Malfunction ·ALCON PRECISION DEVICE - SINKING SPRING·Product code HNN·March 28, 2013

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·March 4, 2011

    CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNUPLASTY RING

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code KRH·April 17, 2008

    3.2MM Pellet Insertion Tray Catalog Number: B7345R1

    FDA Enforcement
    Class II ·Terminated·Busse Hospital Disposables, Inc.·June 8, 2022

    Smith & Nephew FOOTPRINT ULTRA PK SUTURE ANCHOR 4.5 Part Number: 72202901

    FDA Enforcement
    Class II ·Ongoing·Smith & Nephew, Inc.·April 29, 2020

    Spirit Plus Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 2016

    Spirit Select Bed, A-C Powered Hospital Bed

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·August 10, 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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018