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

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    AUTIMO 2.5-D AND AUTIMO 3-D

    FDA 510(k)
    FDA Class 2 ·Radiology

    artegral

    FDA UDI
    Merz Dental GmbH·D7091972016·posteriors; shade A2; size S; upper jaw

    DRIVE

    FDA Adverse Event
    Injury ·HL CORP (SHENZHEN)·Product code ITJ·May 11, 2020

    CUP ELECTRODES, GOLD, REUSABLE, SILVER, REUSABLE; CUP ELECTRODES SILVER/SILVER CHLORIDE REUSABLE

    FDA 510(k)
    FDA Class 2 ·Neurology

    Force Fiber Fusion Suture

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

    TENSION FREE VAGINAL TAPE - ABBREVO UNKNOWN PROD

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·January 4, 2019

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024215061·

    NexGen®

    FDA UDI
    Zimmer, Inc.·00889024215078·

    ATTAIN ABILITY PLUS

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·August 5, 2015

    SYNERGY

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LGW·February 21, 2013

    INSYNC III

    FDA Adverse Event
    Death ·MEDTRONIC S.A.·Product code DXY·January 27, 2011

    CR POR FEM HATCP SIZE E/L SIZE F/L Knee Prosthesis

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

    NexGen Knee CR Porous FEM NexGen Knee CR Precoat FEM prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes "" 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

    NexGen Knee CR Option Fem NexGen Knee CR Porous Fem NexGen Knee CR Precoat Fem NexGen Knee LPS Porous Fem NexGen Knee LPS Precoat Fem prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes 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