Company: Physio-Control, Inc. Date of Enforcement Report 6/22/2016 Class lI: PRODUCT LIFEPAK15 monitor/defibrillator with End-Tidal C02 (EtC02) feature installed. Part numbers: V15-2-xxxxxx (includes software version 1 and version 2); V15-5-xxxxxx (inclues software version 4). The LIFEPAK 15 monitor/defibrillator is intended for use by trained medical personnel in outdoor and indoor emergency care settings within the...Read More

Company: Leica Biosystems Richmond Inc. Date of Enforcement Report 6/22/2016 Class lI: PRODUCT Ariol is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and...Read More