10 results
·
22ms
·
Sources: EU EUDAMED, US FDA
ProSeal Injector Plus (Model no. 421050)
FDA 510(k)
FDA Class 2
·General Hospital
Integra® Jarit®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780187424·Integra® Jarit® Semmes Howard Spinal Curette, 9...
MICRODERM, MODEL/VERSION 3.5
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SMR TT Augmented Glenoid System
FDA 510(k)
FDA Class 2
·Orthopedic
COLLEAGUE 3CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·November 24, 2008
ZEPHYR XL DR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWP·September 9, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 22, 2013
VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for totally adapted use in intensive care, emergencies, pediatrics, neonatology and orthopedics.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code IZL·January 23, 2012
VMX, VMX Plus Mobile Radiographic Unit with the following models: 45296139; 45296200; 45296350; 45296477; 45296964; 45297001; 45296966; 45297003; 2240169; 2240171; 2240172; 2240173. Product Usage: The VMX is a mobile radiography system incorporating stylish design for totally adapted use in intensive care, emergencies, pediatrics, neonatology and orthopedics.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·April 17, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025