87 results
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10ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Terminated
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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
Omega Incline Platform Lift
FDA Enforcement
Class II
·Terminated·Savaria Concord Lifts, Inc.·May 3, 2017
MEE-1000A Neuromaster, Model No. Accessories: MS-110B (Electric Stimulation), MS-120BK (Current Stimulator Box) JB-116B, JB-132B (Amplifiers) Electromyography. (EMG)
FDA Recall
Terminated
·Nihon Kohden America Inc·Product code GWF·January 19, 2012
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
TIBIAL TRAY , SIZE 2, REF 90-SRK-200200, QTY: 1, STERILE R, total knee replacement .
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code JWH·July 18, 2016
TIBIAL TRAY , SIZE 4, REF 90-SRK-200400, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code JWH·July 18, 2016
RESPONSIVE, KNEE: FEMORAL total knee replacement COMPONENT CR/CS, SIZE 3L, REF 90-SRK-312300, QTY: 1, STERILE R,
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code JWH·July 18, 2016
TIBIAL TRAY , SIZE 5, REF 90-SRK-200500, QTY: 1, STERILE R, Responsive Orthopedics, total knee replacement
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code JWH·July 18, 2016
TIBIAL TRAY , SIZE 3, REF 90-SRK-200300, QTY: 1, STERILE R, total knee replacement
FDA Recall
Terminated
·Medtronic Sofamor Danek USA Inc·Product code JWH·July 18, 2016