10 results
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15ms
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Sources: EU EUDAMED, US FDA
Medline Thermistor Foley Catheter 14 FR 5-10 ml, non sterile Catalog Number: 102201101463MD {Medline code 55346) Monitor urinary output and bladder temperature in addition to facilitating urine drainage.
FDA Enforcement
Class II
·Terminated·Degania Silicone, Ltd.·January 22, 2020
Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
FDA Enforcement
Class II
·Terminated·Paltop Advanced Dental Solutions Ltd·October 9, 2019
Paltop Dynamic Dental Implant Dia 3.25mm L 13.0 mm, Catalog Number 21-70020
FDA Enforcement
Class II
·Terminated·Paltop Advanced Dental Solutions Ltd·January 29, 2020
Snapshot Tracker Kit, Mas2659-01, KIT0898, Rx Only, Non Sterile, UDI: 07290109181868
FDA Enforcement
Class II
·Terminated·Mazor Robotics Ltd·January 1, 2020
McKesson Cardiology Hemo
FDA Enforcement
Class II
·Terminated·Change Healthcare Israel Ltd.·June 5, 2019
Horizon Cardiology Hemo
FDA Enforcement
Class II
·Terminated·Change Healthcare Israel Ltd.·June 5, 2019
McKesson Cardiology Hemo, Release SW version 13.0. Used for physiological monitoring, image and data processing. McKesson Cardiology Hemo is intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment. McKesson Cardiology Hemo is also intended for patient/procedural data management, such as documentation, logging, reporting, trending, storing, reviewing, carrying out clinical calculations and exporting various representations of the acquired data.
FDA Enforcement
Class II
·Terminated·McKesson Israel Ltd.·September 12, 2018
NIO-A / NIO-P is an instant IO access device comprises housing with spring load mechanism that injects a trocar needle into the bone marrow of a patient and allows connection of syringe or IV administration set. The NIO-A is intended for adults above 12 years old and the NIO-P is intended for pediatric patients 3 - 12 years of age.
FDA Enforcement
Class II
·Terminated·Waismed Ltd·September 7, 2016
Light Sheer Desire Diode Laser System with XC Handpiece Accessory options.
FDA Enforcement
Class II
·Terminated·Lumenis Limited·May 6, 2015
Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. It is intended to provide increased mobility for elderly and/or disabled person and it is also an aid to independent living. Products can be identified by their color; the recalled products are either metallic blue or metallic silver. The products have two rear wheels and have either one or two wheels in the front. The scooters have an adjustable swivel seat and a front storage basket; some scooters may be fitted with an optional larger rear basket.
FDA Enforcement
Class II
·Terminated·S.A.E. AFIKIM·November 6, 2013