3 results
·
12ms
·
Sources: EU EUDAMED, US FDA
Widefield OCT software feature for the Spectralis HRA+OCT and variants
FDA Enforcement
Class II
·Terminated·Heidelberg Engineering·May 2, 2018
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1003
FDA Enforcement
Class II
·Terminated·Kelyniam Global, Inc.·May 23, 2018
AbsorbENT, Sterile Compressed Absorbent Sponge, Nasal Pack, 8.9cm(L) x 3.0cm (W) x 1.5cm (H), RH-7413-10, Sterilized by Gamma Radiation, Rx only. Used as a nasal packing following intranasal surgery to absorb blood and other fluids in the nasal cavity.
FDA Enforcement
Class II
·Terminated·Summit Medical, Inc.·December 23, 2015