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

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    REACH FEMORAL COMPONENT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PowerPICC Provena

    FDA UDI
    Bard Access Systems, Inc.·00801741141164·Catheter Placement Kit

    Accell TBM

    FDA UDI
    ISOTIS ORTHOBIOLOGICS, INC.·10889981055660·Accell TBM, 7 cm diameter - is made using demi...

    PedFuse

    FDA UDI
    SPINEFRONTIER, INC.·00190361022824·PedFuse ReTurn, Hex, CNL, 7.0mm x 60mm

    NAOS

    FDA UDI
    HNM TOTAL RECON LLC·00841742101019·NAOS First MPJ Hemi, CC - S, 17mm

    GEL MARK BIOPSY SITE MARKER, MODELS MKOOO1, MK0004, MK0007

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

    RX G-UNIVERSAL

    FDA 510(k)
    FDA Class 2 ·Dental

    Alteon

    FDA UDI
    Exactech, Inc.·10885862555694·ALT CUP TRL G7 SIZE 60

    AISYS

    FDA Adverse Event
    Malfunction ·DATEX-OHMEDA, INC.·Product code BSZ·January 15, 2016

    LINOX TD 65/16

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVY·March 12, 2013

    OCTRODE TRIAL LEAD KIT, 60CM LENGTH

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL - NEUROMODULATION DIV.·Product code LGW·February 17, 2011

    CELL-DYN SAPPHIRE ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·February 21, 2008

    BIOLOX DELTA, CERAMIC FEMORAL HEAD, M, 28/0, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER SWITZERLAND MANUFACTURING GMBH·Product code LZO·September 21, 2023

    REVERSE SHOULDER SYSTEM 04.01.0173 GLENOSPHERE 39XØ27

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code PHX·February 6, 2019

    CHYPER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·April 26, 2007

    RINGLOC BI-POLAR 28X42MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·September 11, 2023

    MD HYBRID GLENOID BASE 4MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·August 13, 2018

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 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