BEUDAMED
    16 results · 28ms · Sources: EU EUDAMED, US FDA

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    AMUKIN D

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Tubifast®

    FDA UDI
    Mölnlycke Health Care AB·05055158000742·Tubifast Leggings 11 - 14 yrs x 6

    Inrad

    FDA UDI
    Inrad·00817295020695·SelectCore Variable Throw Biopsy Device 16 ga x...

    SCOTT'S SELECT MICROHYBRID SYRINGE 4.5 Gm (D3)

    FDA UDI
    SCOTT'S DENTAL SUPPLY L.L.C.·D77819920160·Scott’s Select Microhybrid Composite is indicat...

    SUPER-FINE PEN NEEDLE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SMOOV O10

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    NexGen® Legacy®

    FDA UDI
    Zimmer, Inc.·00889024224629·

    NexGen® Legacy®

    FDA UDI
    Zimmer, Inc.·00889024224636·

    PLUM A+ TRIPLE NEW 8

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·January 28, 2016

    ACCU-CHEK ® SPIRIT COMBO

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

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·February 15, 2011

    OT VERIO IQ METER

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

    13X75 MM 4.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE

    FDA Adverse Event
    Injury ·BECTON, DICKINSON & CO.·Product code JKA·July 25, 2017

    13X75 MM 4.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE

    FDA Adverse Event
    Injury ·BECTON, DICKINSON & CO.·Product code JKA·July 25, 2017

    LPS PRECOAT FEM SIZE D-RT LPS PRECOAT FEM SIZE E-RT LPS POROUS FEM SIZE F-RT 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