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

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    SYNTHETIC POWDER FREE (WHITE) VINYL PATIENT EXAMINATION GLOVES

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092104439·Biomet 3i Certain®-compatible 5.0mm X 6mm Titan...

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040062487·Endoflex Reamers 21 mm

    Isolaz

    FDA UDI
    SOLTA MEDICAL·00816995020622·PROFUSION 1 TIP + 30C PK

    GOLDFINGER DEVICE

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

    THERMAL CAUTERY FORCEPS

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

    LINER: VERSAFITCUP DM DOUBLE MOBILITY HC 56/28

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code MEH·July 21, 2021

    8800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 12, 2013

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·February 25, 2011

    RESTORE REVISION SCREWOUT

    FDA Adverse Event
    Malfunction ·DEPUY MITEK·Product code HRX·February 25, 2008

    2.0 LACTOSORB SYSTEM L-PLATE - LEFT - REGULAR

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HRS·June 29, 2018

    2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·June 29, 2018

    2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code JEY·June 29, 2018

    2.0 LACTOSORB SYSTEM 2.0 X 7 MM LACTOSORB SCREW

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·June 29, 2018

    PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·February 18, 2016

    PENUMBRA SYSTEM 5MAX ACE REPERFUSION CATHETER

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·February 18, 2016

    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

    CADD-Solis Ambulatory Infusion Pumps, Model 2100. Intended for the following uses: Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Quadra Assura, Model No. CD3265-40, CD3265-40Q, CD3365-40C, CD3365-40Q. Quadra Assura MP, Model No. CD3269-40, CD3269-40Q, CD3369-40C. Fortify and Fortify Assura implantable cardioverter defibrillators (ICDS) are intended to provided ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing. Unify and Unify Assura cardiac resynchronization therapy defibrillators (CRTDs) are intended to provide ventricular anti-tachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The devices may also be programmed to provide single or dual chamber bradycardia pacing, in additional to cardiac resynchronization therapy via left ventricular pacing

    FDA Enforcement
    Class I ·Terminated·St Jude Medical Inc.·November 2, 2016

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024