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

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    HOFFMANN II EXTERNAL FIXATION SYSTEM 90 DEGREE POST

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Gibralt®

    FDA UDI
    INNO Holdings, Inc.·M711050040038480·Posterior Cervical, Connector, Rod to Rod, 38-4...

    Gibralt

    FDA UDI
    Choice Spine, LP·10885862233516·

    TDK HANDPIECES

    FDA 510(k)
    FDA Class 1 ·Dental

    OMRON INTELLISENSE BLOOD PRESSURE MONITOR, MODEL HEM-907

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TRELLIFORM

    FDA Adverse Event
    Injury ·DSM BIOMEDICAL, INC.·Product code FTM·April 16, 2020

    CR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·March 14, 2013

    ON-Q PAINBUSTER

    FDA Adverse Event
    Injury ·I-FLOW CORP.·Product code MEB·February 24, 2011

    ENDO GIA II 45-3.5 DLU

    FDA Adverse Event
    Injury ·NORTH HAVEN - USS·Product code GAG·February 14, 2008

    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