BEUDAMED
    20 results · 23ms · Sources: EU EUDAMED, US FDA

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    PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    PRESS-MATE PM-2100 VITAL SIGN MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    APTUS 1.5 TRILOCK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 21, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·September 26, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·June 13, 2011

    UNKN SYNERGY HIP STEM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDG·March 15, 2022

    UNKN R3 METAL LINER IMPL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 14, 2022

    UNKN FEM HEAD MEMPHIS CERAMIC

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDG·March 15, 2022

    UNKN R3 SHELL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDG·March 15, 2022

    UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVED MODULAR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 14, 2022

    DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

    FDA Adverse Event
    Injury ·COOK INC·Product code DQO·August 10, 2023

    UNKN R3 METAL LINER IMPL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 14, 2022

    UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVED MODULAR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 14, 2022

    UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH) SLEEVED MODULAR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 14, 2022

    UNKN R3 METAL LINER IMPL

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 14, 2022

    UNKN BIRMINGHAM HIP MODULAR HEAD (BHMH)

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 14, 2022

    SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in Philips MR Intera and Achieva Systems. Model Numbers: 453567141882, 453567141883. Coils may be included in kits with Mode Numbers: 989603014351 & 989603014352.

    FDA Enforcement
    Class I ·Ongoing·Philips North America Llc·July 3, 2024

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable, dedicated programming system which operates using the Merlin PCS Model 3330 software and is designed to interrogate, program, display data from, and test Abbott Medical implantable devices and leads.

    FDA Enforcement
    Class II ·Ongoing·Abbott Medical·January 1, 2025