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

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    PULSION CONTINUOUS PULSE CONTOUR CARDIAC OUTPUT (PICCO) SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Implant Prosthetics

    FDA UDI
    Preat Corporation·00842092104231·3i Certain 4.1mm x 6mm Titanium Base

    Preat

    FDA UDI
    Preat Corporation·00842092169827·Biomet 3i Certain®-compatible 4.1mm X 6.0mm Eng...

    DeRoyal

    FDA UDI
    DEROYAL INDUSTRIES, INC.·00749756603638·PEDIATRIC ANESTHESIA CIRCUIT

    MOXIFLOXACIN, 5 UG, BBL SENSI-DISC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GOLDFINGER DEVICE

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

    2.0MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code JEY·March 11, 2013

    CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code DYE·February 25, 2011

    ACCU-CHEK COMPACT TEST DRUM

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·February 19, 2008

    OXF UNI TIB TRAY SZA LM/RL PMA

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

    OXF ANAT BRG LT MD SIZE 5 PMA

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

    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

    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

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

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