9 results
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17ms
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Sources: EU EUDAMED, US FDA
INSTRUMENT MAKAR GRAVITY ASSIST SYSTEM
FDA 510(k)
FDA Class 1
·General Hospital
CHS
FDA UDI
Smith & Nephew, Inc.·03596010413581·CANNULATED OSTEOTOMY BLADE PLATE CHILD 3 HOLE 35MM
NP 3.3mm Externally Cooled Drill, 8.5 - 15.0mm
FDA UDI
STERNGOLD DENTAL LLC·00841549114977·A metal device used in dental surgery to create...
PAG MICROPROCESSOR-CONTROLLED MODULE
FDA 510(k)
FDA Class 1
·Cardiovascular
LASER FORCEPS HANDPIECE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ISOFLEX OPTIM LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 9, 2013
TALENT THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·November 18, 2010
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code KRG·July 1, 2014
Mako Hip End Effector, Variable Angle Catalog Number: 206967 GTIN:00848486022167
FDA Enforcement
Class II
·Terminated·Mako Surgical Corporation·August 12, 2020