9 results
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19ms
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Sources: EU EUDAMED, US FDA
NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES
FDA 510(k)
FDA Class 1
·Radiology
Xcaliber Bone Screws
FDA UDI
ORTHOFIX SRL·18054242516019·SELF DRILLING XCALIBER CYLINDRICAL SCREW SHAFT ...
Xcaliber Bone Screws
FDA UDI
ORTHOFIX SRL·18054242518655·SELFDRILLING XCALIBER CYLINDRICAL SCREW SHAFT D...
Chemtrue Multi-Panel DOA DIP Card Tests
FDA 510(k)
FDA Class 2
·Clinical Toxicology
TIDI BRAND STERILIZATION WRAP
FDA 510(k)
FDA Class 2
·General Hospital
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·December 30, 2010
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·February 4, 2013
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 17, 2014
The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(ethylene terephtalate)] braids, coated, with or without PLEDGETS of different sizes. CARDIOFLON Evolution 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. CARDIOFLON Evolution sutures comply with the requirements of the United States Pharmacopoeia (USP) and the European Pharmacopoeia (EP) for non-absorbable surgical sutures, except for some diameters. 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 single or double armed (36 sutures), 24 units of ligatures (24 reels), 12 packs for double armed (10 Green or 5 Green/5 White) (120 sutures).
FDA Enforcement
Class II
·Terminated·Peters Surgical·October 1, 2014