8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5
FDA 510(k)
FDA Class 1
·Radiology
Polystar HK
FDA UDI
Merz Dental GmbH·D7091984466·anteriors; shade C2; mould D 68
MODEL #250 DEFIB CABLE
FDA 510(k)
FDA Class 2
·Cardiovascular
HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS
FDA 510(k)
FDA Class 2
·Hematology
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·February 28, 2013
INRATIO
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC·Product code GJS·February 1, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 6, 2014
BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·December 15, 2021