9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Fiber Optic Brushless Electronic Micromotor, model: iM100
FDA 510(k)
FDA Class 1
·Dental
NA
FDA UDI
Zimmer, Inc.·00889024049543·
NA
FDA UDI
Zimmer, Inc.·00889024049550·
NITREX NITINOL GUIDEWIRE
FDA 510(k)
FDA Class 2
·Cardiovascular
U2 TIBIAL BASEPLATE- CMA TYPE, TIBIAL INSERT AND AUGMENT
FDA 510(k)
FDA Class 2
·Orthopedic
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD.·Product code MCM·September 1, 2011
CVC KIT:2-LUMEN 7 FR X 20 CM
FDA Adverse Event
Malfunction
·ARROW INTL INC·Product code DQO·August 1, 2008
ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG
FDA Adverse Event
Injury
·COOK, INC.·Product code MIH·July 9, 2013
Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.
FDA Enforcement
Class II
·Terminated·Stryker Sustainability Solutions·March 13, 2019