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

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    QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    PowerPICC

    FDA UDI
    Bard Access Systems, Inc.·00801741141584·Catheter Placement Kit

    TruForm

    FDA UDI
    Rmo, Inc.·00885797099594·MAN 1ST MOLAR LEFT 87 BANDS

    12Pin 3-Lead Host Cable,Def-P,DIN Conn

    FDA UDI
    Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·06944904038193·

    FOAM CALCIUM ALGINATE TOPICAL WOUND DRESSING WITH COLLAGEN

    FDA 510(k)
    FDA Unclassified ·Unknown

    ELIACHAR LARYNGEAL FOAM STENT, MODEL ELL-1

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    ZPower Rechargeable System for Sophono

    FDA UDI
    ZPOWER, LLC·00850034007106·ZPower Rechargeable System for Sophono Kit Inc...

    OCTRODE LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·February 18, 2016

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 22, 2023

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 14, 2023

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURER GMBH·Product code KTT·August 22, 2023

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·March 12, 2013

    OPTI-FREE REPLENISH

    FDA Adverse Event
    Injury ·ALCON - FORT WORTH / ALCON LABORATORIES, INC.·Product code LPN·February 17, 2011

    SYNCHRON LX20 PRO

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·February 18, 2008

    UNKNOWN TROFIX TROCHANTERIC FIXATION PLATE

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code KTT·August 22, 2023

    qube Compact Monitor (Patient Monitor) 91390. The monitor is 26.2 cm x 31.5 cm x 13.2 cm and weighs 4.1 kg (10.3 inches x 12.4 inches x 5.2 inches - 9 lbs). It has a 26.2 cm (12.1 inches) LCD display with 1024 x 768 resolution. The Spacelabs Healthcare Qube Compact Monitor (91390), functioning as either bedside or central monitors; passively displays data generated by 2 Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the Model 91390 when employing the Spacelabs Command Module, consist of ECU, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. The Qube is intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. The Qube may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow network-based applications to open windows and display information on other networked monitors. The Qube is also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. The Qube is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 28, 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

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012