BEUDAMED
    13 results · 35ms · Sources: EU EUDAMED, US FDA

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    Gemini Bonded Sterilization Wrap

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ACHIEVA FAMILY

    FDA 510(k)
    FDA Class 2 ·Radiology

    NOVEL III SPINAL FIXATION AND ADJUSTABLE BRIDGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·November 13, 2014

    GYNECARE TVT OBURATOR

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·June 3, 2013

    AC-POWERED ADJUSTABLE HOSPITAL BED, INCLUDING RAILS

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code FNL·October 6, 2014

    ZERO TIP NITINOL STONE RETRIEVAL BASKET

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - SPENCER·Product code FFL·June 28, 2011

    UNKN COBLATION ENT DEV

    FDA Adverse Event
    Injury ·ARTHROCARE CORP.·Product code GEI·April 4, 2022

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code GAM·October 1, 2021

    UNK - NAILS: FEMORAL

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·February 26, 2020

    UNKNOWN GII ANCHOR

    FDA Adverse Event
    Malfunction ·DEPUY MITEK LLC US·Product code JDR·October 28, 2019

    AQUAPAK 340 SW, 340, ML W/040, ADAPTOR, JAPA. Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·February 18, 2015

    Philips Allura Xper Interventional Fluoroscopic X-ray Systems, specifically the DIMMs (Dual In-line Memory Modules) used with affected systems. Allura Xper Model Name - Model Number: Allura Xper FD10 722003 722010 722026; Allura Xper FD10/10 722005 722011 722027; Allura Xper FD10C 722001; Allura Xper FD20 722006 722012 722028; Allura Xper FD20 Biplane 722008 722013; Allura Xper FD20 Biplane OR Table 722025; Allura Xper FD20 OR Table 722023 722035; Allura Xper FD20/10 722029; Allura Xper FD20/15 722058; Allura Xper FD20/20 722038; Allura Xper FD20/20 OR Table 722039; (Allura Centron - 722400 is impacted by this recall, but Allura Centron systems are not distributed in the United States.)

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024