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

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    FREEDOM INFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Tubifast®

    FDA UDI
    Mölnlycke Health Care AB·05055158000735·Tubifast Leggings 8 - 11 yrs x 6

    SCOTT'S SELECT MICROHYBRID SYRINGE 4.5 Gm (D2)

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D77819920150·Scott’s Select Microhybrid Composite is indicat...

    PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Faico Dental Implant System

    FDA 510(k)
    FDA Class 2 ·Dental

    NexGen® Legacy®

    FDA UDI
    Zimmer, Inc.·00889024224612·

    NexGen® Legacy®

    FDA UDI
    Zimmer, Inc.·00889024224605·

    RADIFOCUS OPTITORQUE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·June 13, 2022

    ACCU-CHEK ® SPIRIT COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE AG·Product code LZG·March 7, 2013

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·February 15, 2011

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·August 8, 2014

    UNKNOWN GASTROJEJUNAL FEEDING TUBE

    FDA Adverse Event
    Injury ·AVANOS MEDICAL INC.·Product code KNT·October 28, 2018

    UNKNOWN GASTROJEJUNAL FEEDING TUBE

    FDA Adverse Event
    Injury ·AVANOS MEDICAL INC.·Product code KNT·October 28, 2018

    UNKNOWN GASTROJEJUNAL FEEDING TUBE

    FDA Adverse Event
    Injury ·AVANOS MEDICAL INC.·Product code KNT·October 28, 2018

    UNKNOWN GASTROJEJUNAL FEEDING TUBE

    FDA Adverse Event
    Injury ·AVANOS MEDICAL INC.·Product code KNT·October 28, 2018

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·July 8, 2016

    RESOLUTE INTEGRITY RX

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·July 8, 2016

    OPTITORQUE ANGIOGRAPHIC CATHETER

    FDA Adverse Event
    Malfunction ·Product code DQO·January 20, 2021

    LPS PRECOAT SRF HDN FEM SZ D-L LPS PRECOAT SRF HDN FEM SZ D-R LPS PRECOAT SRF HDN FEM SZ E-L LPS POROUS SRF HDN FEM SZ D-LT LPS POROUS SRF HDN FEM SZ E-LT This device is indicated for patients with severe knee pain and disability

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

    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