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

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    ULTRA COMPACT WRIST BLOOD PRESSURE MONITOR WITH INTELLISENSE, MODEL HEM-630

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65810016711·HEDSTROM FILES 25MM

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092104095·Biomet 3i Certain®-compatible 3.4mm Esthetic Ab...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040094294·Maxima Hedstrom Files 25mm

    DELTA 16 TACT

    FDA 510(k)
    FDA Class 2 ·Radiology

    POWDERED LATEX EXAM GLOVES, PINK, WITH/WITHOUT STRAWBERRY SCENT, PROTEIN LABELING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HERO GRAFT

    FDA Adverse Event
    Injury ·CRYOLIFE, INC.·Product code DSY·June 8, 2015

    ALTRX +4 10D 32IDX48OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC. 1818910·Product code LPH·March 13, 2013

    SOLYX SIS SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 25, 2011

    PRECISION XTRA /OPTIUM

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·February 15, 2008

    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code PQF·July 9, 2018

    UNKNOWN OXFORD TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·March 22, 2020

    UNKNOWN OXFORD FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JWH·March 22, 2020

    UNKNOWN OXFORD TIBIAL COMPONENT

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·May 7, 2021

    UNKNOWN OXFORD FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code NRA·May 7, 2021

    DAVINCI XI

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·November 14, 2025

    VELOCITY DELIVERY MICROCATHETER

    FDA Adverse Event
    Malfunction ·PENUMBRA, INC.·Product code DQY·April 13, 2023

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Enforcement
    Class II ·Terminated·Sunrise Medical (US) LLC·December 11, 2013

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 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