BEUDAMED
    19 results · 31ms · Sources: EU EUDAMED, US FDA

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    FLEX-NECK PD CATHETER, INFANT

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

    STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE

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

    BIOSTEON CROSS PIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 5, 2025

    UNKNOWN ORTHOSIS

    FDA Adverse Event
    Injury ·BIOMET SPAIN, S.L.·Product code MNI·January 6, 2017

    RX ACCULINK CAROTID STENT SYSTEM

    FDA Adverse Event
    Death ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code NIM·October 19, 2007

    COBE SPECTRA BLOOD COLLECTION

    FDA Adverse Event
    Malfunction ·TERUMO BCT·Product code GKT·April 2, 2013

    RESTORE RECHARGABLE NEUROSTIMULATOR

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·March 16, 2011

    18 FR GASTROSTOMY TUBE

    FDA Adverse Event
    Malfunction ·ROSS PRODUCTS DIVISION·Product code KNT·April 18, 2008

    KINECTIVE TECHNOLOGY MODULAR NECK

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·June 7, 2018

    NEUTRAL LINER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·June 7, 2018

    SELF TAPPING BONE SCREW

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code LPH·June 7, 2018

    ZIMMER M/L TAPER MODULAR FEMORAL STEM WITH KINECTIV TECHNOLOGY PRESS-FIT

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code LPH·June 15, 2016

    Cobas 8000 Modular Series system; Software Version 05-02 and 06-03; UDI: 05641446001

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·February 28, 2018

    The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.

    FDA Enforcement
    Class II ·Terminated·CHG Hospital Beds Inc·March 23, 2016

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024