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

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    VAULT ALIF SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58211033690·RETRACTOR, ALL TYPES

    UniTip High Resolution Catheter

    FDA UDI
    Unisensor AG·07640172973530·

    RESECTION ABLATOR

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

    LIFECARE COMPACT TENS DEVICE

    FDA 510(k)
    FDA Class 2 ·Neurology

    CAPSUREFIX NOVUS MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·October 7, 2024

    ATTAIN PERFORMA MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·November 4, 2024

    SPRINT QUATTRO SECURE MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code NVY·November 4, 2024

    CAPSUREFIX NOVUS LEAD MRI SURESCAN

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·November 4, 2024

    NEXGEN PROVISIONAL ARTICULAR SURFACE

    FDA Adverse Event
    Malfunction ·ZIMMER BIOMET, INC.·Product code HWT·February 26, 2020

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 9, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 19, 2014

    MERIT CUSTOM KIT

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·May 17, 2011

    VANGUARD MONO FINNED STM TIB 71X14

    FDA Adverse Event
    Malfunction ·BIOMET UK LTD.·Product code JWH·December 9, 2024

    VANGUARD ROCC TIB BRG UHMWPE 60X10MM

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code JWH·September 16, 2025

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    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

    VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)

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

    INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)

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

    ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)

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