9 results
·
26ms
·
Sources: EU EUDAMED, US FDA
T-UPTAKE EIA TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123175·K-WIRE - SINGLE TROCAR THREADED 1.8mm DIA x 150mm
VIEWSEND MEDICAL SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens
FDA 510(k)
FDA Class 2
·Ophthalmic
DWF CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
FDA Adverse Event
Injury
·COOK VASCULAR INC·Product code DWF·December 15, 2016
PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code DXY·February 9, 2013
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 6, 2011
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 23, 2014
Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·March 25, 2020