7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
LENS INSERTION GLIDE
FDA 510(k)
FDA Class 1
·Ophthalmic
FORMA Composite (Shade A3D)
FDA 510(k)
FDA Class 2
·Dental
MODIFICATION TO SAPPHIRE DETACHABLE COIL SYSTEM (TETRIS 3-D)
FDA 510(k)
FDA Class 2
·Neurology
PK DISSECTING FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·May 30, 2014
STERIS SYSTEM 1E
FDA Adverse Event
STERIS CORPORATION - HOPKINS·Product code MED·November 20, 2012
ZIMMER TRABECULAR METAL HUMERAL STEM
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSD·September 17, 2010
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015