16 results
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7ms
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Sources: EU EUDAMED, US FDA
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
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
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
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
Upper roller bracket (part number 1088370) for the Gen2 gantry enclosure for the Radixact Treatment Delivery System.
FDA Enforcement
Class II
·Completed·Accuray Incorporated·September 6, 2023
AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size: 5F; Length: 100cm; designed to accept guidewire: .035 in. --- Catalog No. [REF]: 10734201. Packaged in boxes of 5 catheters each, with manufacturer listed as AngioDynamics, Inc., Queensbury, NY USA. Intended use: angiographic diagnosis.
FDA Enforcement
Class II
·Terminated·Angiodynamics Worldwide Headquarters·August 15, 2012
PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies.
FDA Enforcement
Class II
·Ongoing·Nihon Kohden America Inc·February 3, 2021
GE HealthCare ViewPoint 6, Catalog Number H47601AA; Radiological image processing system
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·December 24, 2025