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

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    OCU-FLEX-53 THIN ZONE TORIC AND THIN ZONE TORIC ASPHERICAL (OCUFILCON) SOFT CONTACT LENSES FOR DAILY WEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SCANLAN® Legacy Micro Forceps

    FDA UDI
    SCANLAN INTERNATIONAL INC·00846159033595·Legacy FRCP FH 1X2MT 1MM DD 10"

    SYNERGY HA COATED POROUS FEMORAL STEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    TRUBYTE DENTURE CLEANSER/POLISHING COMPOUND

    FDA 510(k)
    FDA Class 1 ·Dental

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·UNOMEDICAL A/S·Product code FPA·December 9, 2024

    CS100 INTRA-AORTIC BALLOON PUMP, ENGLISH, 110V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·October 1, 2024

    GORE TAG THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code MIH·November 14, 2008

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·March 1, 2011

    PFC SIGMA C/S NPOR FEM RT SZ 5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, INC.·Product code JWH·February 26, 2008

    AUTOSOFT XC

    FDA Adverse Event
    Malfunction ·Product code FPA·May 24, 2024

    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

    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

    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