The Food and Drug Administration (FDA) is announcing a public workshop entitled “Medical Device Patient Labeling”. The purpose of the public workshop was to discuss issues associated with the development and use of medical device patient labeling including content, testing, use, access, human factors, emerging media formats, and promotion and advertising. The Center for Devices…

<!– –> <!– Page Last Updated: 10/02/2015 –> Page Last Updated: 10/02/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

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…

%PDF-1.7 % 82 0 obj stream

<!– –> <!– Page Last Updated: 09/30/2015 –> Page Last Updated: 09/30/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

<!– –> <!– Page Last Updated: 09/29/2015 –> Page Last Updated: 09/29/2015 <!– –> Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.

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…

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…

%PDF-1.6% 2044 0 objstream htMk@࿲HgFگ} $m #m@՚wlٹDAPޮ;imRF١,`sxsQ6aP?BR+.WD6=8BB4M=فgDl!=SdN2u%Y~ ʌ֒%4Kqh#yk/h91`tJ8^ZײyHQ@`j~M-^wy/7hzwIfyrO)v6bݦjۏaE5.ez^eS9Iݪ?urb/

%PDF-1.5% 49 0 objendobj 72 0 obj/Filter/FlateDecode/ID[]/Index[49 55]/Info 48 0 R/Length 108/Prev 72662/Root 50 0 R/Size 104/Type/XRef/W[1 3 1]stream hbbd“`b“:”d=02m”I% “ABXDW@s LFo@L@