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

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    InMode System with vTone Applicator

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777655·LUMBAMED BASIC DORSAL STAYS M SILVER III

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04049772777600·LUMBAMED BASIC DORSAL STAY WM SILVER III

    Integra® Jarit®

    FDA UDI
    INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780372080·Integra® Jarit® Volkman Retractor, 9", USA Patt...

    OSTEONICS SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY

    FDA 510(k)
    FDA Class 2 ·Radiology

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 5, 2023

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 2, 2017

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·January 25, 2017

    MECHANICAL WALKER, ROLLATOR

    FDA Adverse Event
    UNKNOWN·Product code ITJ·October 24, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 1, 2013

    NucliSENS¿ Magnetic Extraction Reagents

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·October 31, 2018

    NucliSENS magnetic extraction reagents, For in vitro diagnostic use, Product Usage: NucliSENS miniMAG¿ is intended to be used for the extraction of total nucleic acids from biological specimens.

    FDA Enforcement
    Class I ·Terminated·BioMerieux SA·January 25, 2017

    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

    FDA Enforcement
    Class II ·Completed·Mako Surgical Corporation·November 25, 2020

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·February 3, 2021