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

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    AMSCO WARMING CABINET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Leva® Anterior Expandable Spacer System

    FDA UDI
    Spine Wave, Inc.·10840642109320·Spacer, 26 mm (W) x 26 mm (D) x 19 mm (H), 8° L...

    PENUMBRA SYSTEM SEPARATOR FLEX (026,032,041,054), MODELS PSF026, PSF032, PSF041, PSF054

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    EPISIL

    FDA 510(k)
    FDA Unclassified ·Unknown

    TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN

    FDA Adverse Event
    Malfunction ·TAMBRANDS MANUFACTURING, INC·Product code HEB·March 10, 2021

    TAMPAX RADIANT TAMPON UNSCENTED, ABSORBENCY UNKNOWN

    FDA Adverse Event
    Malfunction ·TAMBRANDS MANUFACTURING, INC·Product code HEB·March 3, 2021

    POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code LIT·May 14, 2013

    MOTORIZED 3-WHEELED VEHICLE FOR OUTSIDE TRANSPORT

    FDA Adverse Event
    C.T.M. SHANGHAI·Product code INI·September 23, 2014

    SYBRONPRO TL

    FDA Adverse Event
    Injury ·EBI INC.·Product code DZE·June 1, 2011

    ENDOWRIST

    FDA Adverse Event
    Injury ·INTUITIVE SURGICAL, INC·Product code NAY·October 6, 2022

    BD PHOENIX¿ AP

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO. (SPARKS)·Product code JQX·September 20, 2022

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 2012

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020

    Smiths Medical Medfusion Model 3500 Syringe pumps, Item Numbers: a) 3500 b) 3500-0600-00 c) 3500-0600-01 d) 3500-0600-249 e) 3500-0600-50 f) 3500-0600-51 g) 3500-0600-82 h) 3500-306 i) 3500-402 j) 3500-414 k) 3500-415 l) 3500-500 m) 3500E n) 3500VX-306 o) 3500VX-500

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209

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