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

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    ACCUBLADE (ACS MODEL), MK8507, ACCUBLADE (HANSOTOME MODEL), MK8508

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    WATER PIK(R)

    FDA 510(k)
    FDA Class 1 ·Dental

    ELECTRO-BLEND EPILATOR, MODEL UC-3

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    NexGen® Legacy®

    FDA UDI
    Zimmer, Inc.·00889024224810·

    NexGen® Legacy®

    FDA UDI
    Zimmer, Inc.·00889024224803·

    LCCK FEM IMPLANT SZ C-L LCCK FEM IMPLANT SZ C-R LCCK FEM IMPLANT SZ D-R LCCK FEM IMPLANT SZ E-L LCCK FEM IMPLANT SZ E-R LCCK FEM IMPLANT SZ F-L LCCK FEM IMPLANT SZ F-R This device is indicated for patients with severe knee pain and disability

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 21, 2018

    LEFT 16MM VARIABLE ANGLE SCREW

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code KWQ·February 27, 2013

    FREESTYLE FREEDOM LITE

    FDA Adverse Event
    Injury ·Product code NBW·February 16, 2011

    HUDSON PEDIATRIC BREATHING CIRCUIT, 30"

    FDA Adverse Event
    Malfunction ·TELEFLEX·Product code OFP·July 24, 2014

    NEXGEN LCCK ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·.·Product code JWH·February 4, 2016

    NEXGEN LEGACY CONSTRAINED CONDYLAR KNEE ARTICULAR SURFACE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·July 21, 2016

    ST PRC TIB PLT SIZE 4

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·August 7, 2018

    STERRAD® NX STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·February 20, 2018

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE-CONSTRAINED CONDYLAR KNEE (LCCK) ARTIC

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·July 1, 2019

    NEXGEN COMPLETE KNEE SOLUTION LEGACY KNEE - CONSTRAINED CONDYLAR (LCCK) FEMORAL

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·July 1, 2019

    NEXGEN COMPLETE KNEE SOLUTION STEM EXTENSION STRAIGHT

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·July 1, 2019

    NEXGEN COMPLETE KNEE SOLUTION STEM EXTENSION STRAIGHT

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JWH·July 1, 2019

    ALL POLY PATELLA SIZE 1 8 MM THICKNESS

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JWH·August 7, 2018

    NexGen Knee LPS Porous FEM NexGen Knee LPS Option FEM NexGen Knee Lock FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Product Usage "" This device is indicated for patients with severe knee pain and disability due to: Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis. Collagen disorders, and/or avascular necrosis of the femoral condyle. Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy. Moderate valgus, varus, or flexion deformities. The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery. " CR and LPS porous coated femoral and tibial baseplate components may be used cemented or uncemented (biological fixation). The CR Hydroxyapatite/tricalcium phosphate [HA/TCP] coated femoral or tibial baseplate components may only be used uncemented. All other femoral, tibial baseplate and all-polyethylene patella components are indicated for cemented use only."

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·March 2, 2016