BEUDAMED
    48 results · 10ms · Sources: EU EUDAMED, US FDA

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    00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile; 00595501202 Provisional CR-FLEX FEM PROV SZ B-R, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

    FDA Recall
    Terminated ·Zimmer, Inc.·Product code JWH·June 7, 2013

    00595501201 Provisional CR-FLEX FEM PROV SZ B-L, Rx, Sterile; 00595501202 Provisional CR-FLEX FEM PROV SZ B-R, Rx, Sterile; Used in total knee arthroplasty and indicated for patients with severe pain.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·August 28, 2013

    Savaria SL-1000 Stairlift

    FDA Enforcement
    Class II ·Terminated·Savaria Concord Lifts, Inc.·May 17, 2017

    TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

    TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

    RESPONSIVE, KNEE: FEMORAL COMPONENT CR/CS, SIZE 3R, REF 90-SRK-311300, QTY: 1, STERILE R,

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

    TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

    Minstrel Patient Lift; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 60172; model numbers HMB001-US and HMB002-US (with scale)

    FDA Recall
    Terminated ·Arjo, Inc.·Product code FSA·April 30, 2004

    TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

    RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 4R, REF 90-SRK-311400, QTY: 1, STERILE R,

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

    RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 5R, REF 90-SRK-311500, QTY: 1, STERILE R,

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

    RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R,

    FDA Enforcement
    Class II ·Terminated·Medtronic Sofamor Danek USA Inc·August 31, 2016

    LPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP SZ C-R LPS FEM COMP SZ D-L LPS FEM COMP SZ D-R LPS FEM COMP SZ E-L LPS FEM COMP SZ E-R LPS FEM COMP SZ F-L LPS FEM COMP SZ F-R LPS FEM COMP SZ G-L LPS FEM COMP SZ G-R This device is indicated for patients with severe knee pain and disability

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code NJL·November 29, 2017

    Omega Incline Platform Lift

    FDA Enforcement
    Class II ·Terminated·Savaria Concord Lifts, Inc.·May 3, 2017

    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz

    FDA Recall
    Terminated ·LivaNova USA·Product code DWC·April 20, 2018

    Sorin Stockert Heater-Cooler System 3T, a) Item #: 16-02-81, 240 v/60 Hz; b) Item #: 16-02-82, 208 v/60 Hz; c) Item #: 16-02-85, 120 v/60 Hz

    FDA Enforcement
    Class II ·Terminated·LivaNova USA·May 30, 2018

    LPS FEM COMP SZ B-L LPS FEM COMP SZ B-R LPS FEM COMP SZ C-L LPS FEM COMP SZ C-R LPS FEM COMP SZ D-L LPS FEM COMP SZ D-R LPS FEM COMP SZ E-L LPS FEM COMP SZ E-R LPS FEM COMP SZ F-L LPS FEM COMP SZ F-R LPS FEM COMP SZ G-L LPS FEM COMP SZ G-R This device is indicated for patients with severe knee pain and disability

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

    Perkin Elmer 226 Sample Collection Device, Serial numbers: 06132903 - 06198900. The PerkinElmer 226 Sample Collection Devices are intended to be used as a medium to collect and transport whole blood specimen spots to a laboratory, in newborn screening. The device includes a tear-apart form for the collection of demographic information.

    FDA Enforcement
    Class II ·Terminated·Perkin Elmer Health Sciences, Inc.·October 30, 2013

    Minerva-Combi Patient Lift, model ML-30; this lift comes with interchangable passive and active lifting units; Manufactured by Medibo-Technics, Hasseltsebaan 24, 3940 Hechtel-Eksel, Belgium and distributed by MasterCare Patient Equipment, Inc., Hwy 61 West Industrial Park, Columbus, NE 68601

    FDA Recall
    Terminated ·Medibo N.V. Heikant 5 Hanmont, Achel Belgium·Product code FSA·August 4, 2004

    MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)

    FDA Enforcement
    Class II ·Terminated·Nihon Kohden America Inc·February 24, 2016