8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
RxSight® Insertion Device
FDA 510(k)
FDA Class 1
·Ophthalmic
Integra® Miltex®
FDA UDI
INTEGRA LIFESCIENCES PRODUCTION CORPORATION·10381780425656·Integra® Miltex® Smithwick Sympathectomy Hook a...
Nanova Interference Screw
FDA 510(k)
FDA Class 2
·Orthopedic
SURGI-MAX
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
UNIFY CRT-D
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D·Product code NIK·January 11, 2014
TI RIB HOOK
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MDI·September 20, 2011
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 2, 2013
MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the anatomy of interest that can be interpreted by a trained physician.
FDA Enforcement
Class III
·Terminated·Invivo Corporation·October 28, 2020