8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Endoscopic Water Pump
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JMS Sysloc A.V. Fistula Needle Set
FDA UDI
JMS SINGAPORE PTE LTD·08888483006113·SYSLOC AVF 17GX1" BE 15CM W/CLAMP HAE-L/N 03016-17
NEWGEL AND NEWGEL PLUS E
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NOVASHIELD INJECTABLE NASAL PACKING AND STENT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
CAPROSYN 3/0
FDA Adverse Event
Injury
·NORTH HAVEN - USS·Product code GAN·November 19, 2008
ACCU-CHEK ® MULTICLIX
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code FMK·September 9, 2011
LYNX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTN·July 22, 2013
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025