11 results
·
18ms
·
Sources: EU EUDAMED, US FDA
N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290114692144·Final Drill for Ø3mm Implant, Short
Paltop
FDA UDI
PALTOP ADVANCED DENTAL SOLUTIONS LTD·07290114695121·Final Drill for Ø3mm Implant, Short
TRIO LX SMALL CONNECTOR
FDA Adverse Event
Malfunction
·STRYKER SPINE BORDEAUX·Product code MNI·March 23, 2011
MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML)
FDA 510(k)
FDA Class 2
·Microbiology
CS/3 CRITICAL CARE MONITOR WITH S-ICU99(A)
FDA 510(k)
FDA Class 2
·Cardiovascular
RAD-57 CONFIGURABLE PULSE CO-OXIMETER
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·June 24, 2019
PLM MICDRP NITRO OL
FDA Adverse Event
Malfunction
·HOSPIRA HOLDINGS DE COSTA RICA LTD.·Product code FRN·April 15, 2013
PFC SIGMARP STB TB IN 2.5 12.5
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code NJL·April 25, 2011
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·July 9, 2008
Silhouette Paradigm 13mm, 18"; Silhouette 43"; Silhouette 23"; Silhouette Paradigm 43"; Silhouette Paradigm 23"; Silhouette Paradigm 13mm, 23"; Silhouette Paradigm 13mm, 43"; Silhouette Paradigm 13mm, 32"; Silhouette Paradigm 32" The products are used in combination with insulin infusion pumps for continuous subcutaneous infusion of insulin
FDA Enforcement
Class II
·Terminated·Unomedical As·November 9, 2016