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

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    LIPSONIX(R) SYSTEM MODEL 2

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

    APEX®

    FDA UDI
    B. BRAUN MEDICAL INC.·04046955747917·DCB APEX 4000ML SINGLE PACK

    n/a

    FDA UDI
    HANS RUDOLPH, INC.·00874750006625·1410A 2W NRBV TSHP SM 22/15MM

    ONE TOUCH ULTRA 2 METER

    FDA Adverse Event
    Malfunction ·LIFESCAN·Product code NBW·March 31, 2011

    NEXIVA 24 G 3/4 INCH

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND CO.·Product code FMI·April 10, 2015

    OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01

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

    GMK-SPHERE TIBIAL INSERT FIXED SPHERE CR SIZE 4/12 MM R

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·June 21, 2022

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code DQX·May 14, 2013

    ASR UNI FEMORAL IMPL SIZE 58

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 19, 2011

    HARMONIC ACE 36 CM

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code LFL·August 11, 2008

    HOLDING SLEEVE 105MM

    FDA Adverse Event
    Malfunction ·SYNTHES BETTLACH·Product code FZX·March 14, 2017

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Model Number L131, ESSENTIO DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021