6 results
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7ms
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Sources: EU EUDAMED, US FDA
InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product Usage: The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hypothermia, to achieve and/or maintain normothermia, and for use in fever reduction. K080908
FDA Enforcement
Class II
·Terminated·Philips Healthcare·February 5, 2014
Her2/Neu (c-erbB-2) (CB-1 1); 7.0 mL Catalog number 237M-18. In vitro diagnostic use - Analyte Specific Reagent Immunology - Analyte Specific Reagent
FDA Enforcement
Class II
·Terminated·Cell Marque Corporation·June 7, 2017
KY LIQUIBEADS Vaginal Moisturizer; Distributed By: McNeil-PPC, Inc. Skillman, NJ 08558-9418; UPC 380041087704; 380040087958. Personal lubricant
FDA Enforcement
Class II
·Terminated·Mc-NEIL-PPC, Inc.·October 3, 2012
KY TINGLING JELLY Personal Lubricant. The product is packaged into 5 oz tubes with the UPC printed on it. Distributed By: McNeil-PPC Inc.
FDA Enforcement
Class II
·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013
KY SilkE Vaginal Moisturizer and Personal Lubricant. The product is packaged in 2.5 oz bottles, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
FDA Enforcement
Class II
·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013
KY SENSITIVE TM JELLY Personal Lubricant. The product is packaged into 3 oz tubes, which are then packed into a printed carton. Distributed by McNeil-PPC Inc.
FDA Enforcement
Class II
·Terminated·Mc-NEIL-PPC, Inc.·March 6, 2013