9 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CORE AUDIBLE TROCAR II
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Armada
FDA UDI
Nuvasive, Inc.·00887517234865·Armada Ti 3CO Osteotome, 7mm Lum Ang
Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Imipenem-Relebactam in the dilution range of 0.03/4-256/4 ug/mL
FDA 510(k)
FDA Class 2
·Microbiology
MEDLINE RED RUBBER URETHRAL CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCESS FREE T4 REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code CEC·April 23, 2012
ASR UNI FEMORAL IMPL SIZE 47
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·March 7, 2013
MAXIMO VR
FDA Adverse Event
Death
·MEDTRONIC S.A.·Product code LWS·February 15, 2011
AIGIS-R LARGE
FDA Adverse Event
Injury
·TYRX, INC.·Product code FTL·August 8, 2014
The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene terephtalate)] braids, with or without PLEDGET of different sizes. CARDIOXYL braids are coated with polysiloxane. CARDIOXYL sutures are green dyed (D&C green # 6, CI 61565) and white (undyed). Some packs are composed of green and white braids to facilitate location during use. CARDIOXYL sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures. Type of packaging: - Unit: Sutures are packed in a support card Onepak or in a pack under an external polyethylene/ paper peel pouch. - Box: 36 units for double armed (36 sutures), 24 units for ligatures (24 reels), 12 packs for double armed (5 Green/5 White) (120 sutures).
FDA Enforcement
Class II
·Terminated·Peters Surgical·October 1, 2014