16 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DURAFILL BOND
FDA 510(k)
FDA Class 2
·Dental
MILLENNIUM
FDA UDI
Avalign Technologies, Inc.·00190776321253·Cottle Heavy Septum Scissors
SURGASSIST RIGHT ANGLE LINEAR CUTTER 30MM, 45MM & 60MM, MODELS RALC30, RALC45 & RALC60
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SYSTEMS INTEGRATION
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·January 15, 2013
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
ENDOTAK RELIANCE
FDA Adverse Event
Malfunction
·CPI - DEL CARIBE·Product code NVY·July 9, 2014
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
PENTAX
FDA Adverse Event
Injury
·PENTAX·Product code EOQ·January 10, 2017
Stryker Orthopaedics, Definition PM Femoral Hip Stem Catalog Numbers 6265-3-099 through 6265-3-107. Howmedica Osteonics Corp. 325 Corporate Drive, Mahwah, NJ 07430. A subsidiary of Stryker Corp. Stryker France, ZAC Satorlas Green Pusignan, Av De Satolas Green 69881 Meyzeiu, Cedex France. Made in Ireland. The Definition PM femoral hip stem is a forged, collared, straight stem with an integral premantle (PM) design. The Poly Methyl Methacrylate (PMMA) and Barium Sulphate (BaSO4) premantle is integral to the design as it aligns, centralizes and pressurizes the stem within the femoral canal. The forged stem is first grit blasted proximally and then the premantle is applied through an infection molding process.
FDA Enforcement
Class II
·Terminated·Stryker Howmedica Osteonics Corp.·July 18, 2012