8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
VITROS Immuodiagnostic Products CA 125 II Reagent Pack
FDA 510(k)
FDA Class 2
·Immunology
Sklar®
FDA UDI
SKLAR CORPORATION·10649111364037·OPER SCISS DEL STR B/B 5 1/2"
ENDOSSEOUS IMPLANT
FDA 510(k)
FDA Class 2
·Dental
WRIST-TYPE FULLY AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR
FDA 510(k)
FDA Class 2
·Cardiovascular
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·November 3, 2014
PAINSMART IOD
FDA Adverse Event
Malfunction
·MOOG DEVICE GROUP·Product code FRN·July 1, 2013
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024