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Industry E-mail About Functional Equivalence Of Transition Tyvek
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Class I Medical Device Recall: MicroPort Orthopedics Inc., PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254
Recall Class: Class I Date Recall Initiated: August 7, 2015 Product: PROFEMUR Long Cobalt Chrome 8 Degree Varus/Valgus Modular Neck, Part 1254 All lots are affected Manufactured from: June 15, 2009 to July 22, 2015 Distributed from: June 15, 2009 to July 31, 2015 Devices Recalled in the U.S.: 10,825 Use: MicroPort Orthopedics has a…
DuPont Letter Regarding Transition Tyvek
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Screen-film mammography: Headed the way of xeromammography?
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FY2016 MDUFA User Fees
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Posted Discussion Paper and Agenda for Public Workshop – Physiological Closed-Loop Controlled Devices, October 13
The Food and Drug Administration (FDA) is announcing a public Workshop entitled “Physiological Closed-Loop Controlled (PCLC) Devices.” The topic to be discussed is challenges related to the design, development, and evaluation of critical care PCLC devices. FDA considers PCLC devices an emerging technology and aims to hold a workshop focusing on design, development and performance…
Cranial Perforators with an Automatic Clutch Mechanism, Failure to Disengage: FDA Safety Communication
Date Issued: September 28, 2015 Audiences: Neurological Surgeons Device: Cranial perforators are bone cutting and drilling medical devices used to create a small hole (burr hole) in a patient’s skull so that a neurosurgeon can access the brain during certain procedures. These devices often include a clutch mechanism that is designed to automatically disengage or…
MedSun October 2015 Newsletter
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Webcast Recording posted for Sept. 24, 2015 Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee Meeting
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