6 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FOUNDATION METAL-BACKED PATELLA
FDA 510(k)
FDA Class 2
·Orthopedic
1) PINION PDO Knotless Suture - Absorbable Poly (P-Dioxanone) Knotless Suture; 2) PINION PGA-PCL Knotless Suture - Absorbable Polyglycolic Acid - Poly (Glycolide-Co-Caprolactone) Knotless Suture
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO MULTITRANS CULTURE COLLECTION AND TRANSPORT SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
HEARTMATE II LVAS
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·January 25, 2013
ACCESS 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·December 17, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 14, 2014