BEUDAMED
    44 results · 29ms · Sources: EU EUDAMED, US FDA

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    CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for human use, SENSATION and SENSATION PLUS IABC demonstration units. Part Number 0998-00-0800-xx; 0998-00-3023-xx; 0998-UC-0800-xx; 0998-UC-3023-xx An electromechanical system used to inflate and deflate intra-aortic balloons.

    FDA Recall
    Terminated ·Maquet Datascope Corp Cardiac Assist Division·Product code DSP·December 16, 2014

    PRCT MIS CR MOB PLT prosthesis, knee, patellofemorotibial, semi-constrained, metal/polymer, mobile bearing 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-Flex porous coated femoral components may be used cemented or uncemented (biological fixation). CR-Flex HA/TCP porous coated femoral components may only be used uncemented. All other femoral and tibial baseplate components are indicated for cemented use only. " CR-Flex Mobile articular surfaces are intended for use with a functional posterior cruciate ligament (PCL). UC-Flex Mobile articular surfaces are intended for use with an absent or deficient PCL. " Specific uses with CR-Flex femorals: Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. The CR-Flex femoral, when used with CR-Flex Mobile or UC-Flex Mobile articular surfaces, is intended for use when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees."

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code NJL·January 11, 2016

    The LCS COMPLETE P.F.C.TM SIGMA RP Mobile Bearing Total Knee System - Product Usage: consists of three components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code NJL·February 22, 2021

    The ATTUNE Rotating Platform (RP) Total Knee System - Product Usage: consists of multiple components intended to replace the femoral, tibial, and patellar articular surfaces of the knee joint.

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code NJL·February 22, 2021

    ATTUNE FIXED BEARING KNEE - Product Usage: composed of individually packaged femoral, tibial and patellar components designed to replace the natural articular surface of the knee joint. The femoral component is a metal implant without a porous coating. The tibial component may be an all polyethylene component or comprised of a metal tibial base without porous coating, and a polyethylene insert and locking components. The patella component may be of an all polyethylene design.

    FDA Recall
    Terminated ·DePuy Orthopaedics, Inc.·Product code JWH·February 22, 2021

    CR Flex GSF Precoat Fem Natural Knee GSF NP Flex Natural Knee GSF POR Flex Natural Knee GSM NP Flex Natural Knee GSM POR Flex prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer various sizes Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). " Components without CSTi porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. " The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen CR-Flex Mobile*, NexGen UC-Flex Mobile*, NexGen Trabecular Metal" CR Monoblock, 90-prefix NexGen CR, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees."

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code JWH·January 11, 2016

    Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.

    FDA Enforcement
    Class II ·Terminated·Clerio Vision·January 20, 2021

    Clerio Vision, extreme H2O monthly, MED, DIA 14.0 PWR -2.25, UPC 675506803334 (6 count) and UPC 675506804478 (12 count) - Product Usage: for daily wear is indicated for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit astigmatism of 0.75 Diopters or less that does not interfere with visual acuity.

    FDA Recall
    Terminated ·Clerio Vision·Product code LPL·December 10, 2020

    Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes.

    FDA Recall
    Terminated ·sanofi-aventis US, Inc. Route 202-206·September 21, 2012

    VentStar Coax (P) 150, MP00379

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BZO·April 17, 2023

    VentStar Anesthesia WT (P)180, MP00374

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CAI·April 17, 2023

    ID Coax 180, MP03375

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BZO·April 17, 2023

    VentStar Watertrap (N) 180, MP00363

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CAI·April 17, 2023

    Anesthesia Circuit Kit Coax 1, MP02730

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CAI·April 17, 2023

    Set2Go Ventilation 12 (A), MP07968

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CAI·April 17, 2023

    Ventstar Coax, MP03373

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BZO·April 17, 2023

    Ventstar Coax 230, MP03376

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BZO·April 17, 2023

    Anesthesia Circuit Kit Coax HEPA, MP17102

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CAI·April 17, 2023

    VentStar breathing bag Set (P) 110, MP00384

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code BTC·April 17, 2023

    VentStar Basic (P)250, MP00352

    FDA Recall
    Terminated ·Draeger Medical, Inc.·Product code CAI·April 17, 2023