3 results
·
7ms
·
Sources: EU EUDAMED, US FDA
Philips Cisco 3850 layer 3 switch, 865339 model WS-C3850-12S-E in use with IntelliVue Information Center iX or Classic Information Center
FDA Enforcement
Class II
·Terminated·Philips Electronics North America Corporation·February 1, 2017
CoaguChek XS Pro meters (catalog number 05530199160)bar code scanner. Used with the CoagCHEK XS Pro Meters to quantitatively determines prothrombin time ("PT").
FDA Enforcement
Class II
·Terminated·Roche Diagnostics Operations, Inc.·April 24, 2013
Integra¿ Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536 The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneiform joint to reposition and stabilize a metatarsus primus varus, Lisfranc arthrodesis, Mono or bi-cortical osteotomies or fractures near the 1st metatarsocuneiform joint.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corp.·August 8, 2012