16 results · 21ms · Sources: EU EUDAMED, 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