3 results
·
15ms
·
Sources: EU EUDAMED, US FDA
NeuRx Diaphragm Pacing System (NeuRx DPS) External Pulse Generator (EPG), Part No. 23-0021.
FDA Enforcement
Class I
·Terminated·Synapse Biomedical Inc·August 31, 2022
Regard Dressing change kit, Item Number 800026006
FDA Enforcement
Class I
·Terminated·ROi CPS LLC·January 10, 2024
regard Operative LAP, Item Number 800943001; surgical convenience kit
FDA Enforcement
Class I
·Terminated·ROi CPS LLC·January 24, 2024