9 results
·
17ms
·
Sources: EU EUDAMED, US FDA
JAMES SURGICAL SYSTEM J1000
FDA 510(k)
FDA Class 2
·Ophthalmic
FOOT VALVE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PALOMAR LUX1540 HANDPIECE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUX 1440
FDA Adverse Event
Malfunction
·PALOMAR MEDICAL TECHNOLOGIES, INC.·Product code GEX·May 5, 2012
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 24, 2014
SOLETRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code MHY·October 22, 2010
RIATA ACTIVE FIXATION
FDA Adverse Event
Malfunction
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·December 28, 2012
LOGIC TIBIA IMPLANT PSC INSERT, SZ 3, 15MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 27, 2024
Bivona Aire-Cuf Endotracheal Tube
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·November 3, 2021