8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERILE IMPERVIOUS ORTHOPEDIC STOCKIN
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
VITROS
FDA UDI
ORTHO-CLINICAL DIAGNOSTICS, INC.·10758750000067·VITROS Chemistry Products TDM Performance Verif...
INNOVO
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2
FDA 510(k)
FDA Unclassified
·Unknown
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 2, 2014
XIA 3 TITANIUM BLOCKER
FDA Adverse Event
Injury
·STRYKER SPINE BORDEAUX·Product code NKB·October 12, 2012
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·May 22, 2015
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015