BEUDAMED
    25 results · 23ms · Sources: EU EUDAMED, US FDA

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    LASSOSTAR NAV Circular Mapping Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Comprehensive® SRS

    FDA UDI
    Biomet Orthopedics, LLC·00880304540736·

    PMT® Halo Systems

    FDA UDI
    PMT CORPORATION·00650551112303·HALO, 1203-5 VEST MEDIUM, LAMBSWOOL LINER, 1211...

    ASCENT KNEE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    GMD UNIVERSAL URINARY INCONTINENCE SLING

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

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014

    SOFT-VU ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code DQO·July 12, 2011

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 8, 2013

    COMP RVS TRAY CO 44MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·September 15, 2020

    MINI +10MM THICKNESS +0MM TAPER OFFSET 40MM DIAMETER HUMERAL TRAY

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·March 5, 2024

    +3MM RETENTIVE THICKNESS 40MM DIAMETER BEARING

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWS·March 5, 2024

    Y-90 THERASPHERE (3 GBQ) CANADA COMM

    FDA Adverse Event
    Death ·BIOCOMPATIBLES UK LIMITED·Product code NAW·June 23, 2021

    UNK HUMERAL TRAY TAPER

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PHX·May 2, 2025

    UNKNOWN

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·November 17, 2016

    UNKNOWN - MAXON

    FDA Adverse Event
    Injury ·DAVIS & GECK CARIBE LTD·Product code GAM·September 6, 2023

    ENDO GIA

    FDA Adverse Event
    Injury ·COVIDIEN LP LLC NORTH HAVEN·Product code GDW·September 6, 2023

    COMP RVRS SHLDR GLNSP STD 36MM

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code PAO·January 7, 2019

    LIGACLIP ENDO

    FDA Adverse Event
    Injury ·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code FZP·August 14, 2017

    Knee Products: 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM 183744 Vanguard Knee System, PS+ Tibial Bearing, 14 MM, 71/75 MM 183742 Vanguard Knee System, PS+ Tibial Bearing, 12 MM, 71/75 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM EP-183608 Vanguard Knee System, PS Tibial Bearing, E1 Infused, 18 MM X 59 MM Product Usage: Knee prosthesis

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·June 3, 2020

    Knee Products: US154709 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B8 US154722 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D5 US154725 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 US154705 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B6 US154707 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, B7 US154713 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C5 US154719 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C8 US154720 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, D4 US154721 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D4 US154723 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D5 US154725 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D6 US154727 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 US154727 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, D7 US154731 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, E4 US154735 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, E6 US154745 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6 US154745 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, A6 US154746 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, A7 US154711 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C4 US154734 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, E6 US154730 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Left Medial/Right Lateral, E4 US154711 Knees Vanguard M Partial Knee System MonoBlock Tibial Tray, Right Medial/Left Lateral, C4 Product Usage: Knee prosthesis

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·June 3, 2020