BEUDAMED
    19 results · 20ms · Sources: EU EUDAMED, US FDA

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    MULTISTIM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890113080·Zirlux Titanium Blank Abutment compatible with:...

    Ovation Tribute Hip Stem

    FDA UDI
    Ortho Development Corporation·00822409011292·EXT SIZE 8 Stem Plasma Spray

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024038·Paddle Shaver, 8mm

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103080·Shaver, Closed, 8mm

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0112080·Tap, 7.50mm

    Universal LeadConfirm cable holder silicone sleeve - Pack of 5

    FDA UDI
    ALPHA OMEGA ENGINEERING CO. LTD.·27290114061388·

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE FLEX SIZE 5/10 MM L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·January 12, 2022

    TAPER-LOCK DENTAL IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    MODIFICATION TO ZYMED TELEMETRY SYSTEM, MODEL EASIVIEW

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SCR REPLACEMENT SW-V GOLD COPING

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·October 19, 2017

    SCR FIXATION REPLACE SPEC TRA-CONE & TAPERED ABU

    FDA Adverse Event
    Malfunction ·ZIMMER DENTAL·Product code DZE·December 8, 2020

    SPINAL VERTEBRAL BODY REPLACEMENT DEVICE

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQP·July 3, 2018

    CD HORIZON

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code KWP·March 15, 2017

    SM304 M-SERIES W/ZOOM

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL-KALAMAZOO·Product code INK·March 19, 2013

    CORAIL AMT STEM STANDARD KS15

    FDA Adverse Event
    Injury ·DEPUY FRANCE S.A.·Product code KWA·March 4, 2011

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·March 11, 2008

    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

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015