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

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    MEDTRONIC PS MEDICAL NEUROPEN ENDOSCOPE AND OPTICAL ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Neurology

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·00304040015544·Retreat w/Epi

    SCANLAN® Titanium Forceps

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159003864·S LEGACY Mic fcp, RH, NS DG, str 1.0 mm DD pft,...

    SECURE FLOW

    FDA Adverse Event
    Injury ·WOO YOUNG MEDICAL INC.·Product code MEB·March 27, 2012

    CLEARFIL REPAIR

    FDA 510(k)
    FDA Class 2 ·Dental

    SOMATOM EMOTION MS

    FDA 510(k)
    FDA Class 2 ·Radiology

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·March 12, 2013

    ENDOPATH** XCEL* TROCAR

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GCJ·March 1, 2011

    HAND-TROL

    FDA Adverse Event
    Malfunction ·CONMED ELECTROSURGERY·Product code GEI·January 28, 2008

    G7 STRAIGHT MONOBLOCK ACETABULAR SHELL INSERTER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PBI·October 3, 2016

    G7 STRAIGHT MONOBLOCK ACETABULAR SHELL INSERTER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code PBI·October 3, 2016

    Ultraview SL 91493 Integrated Module Housing. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated; (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission. Through this network, a patient's data may be displayed at the bedside monitor, central station or clinical information system.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·September 26, 2012

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

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

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