11 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UBI MAGIWEL(TM) IGE QUANTITATIVE AND QUALITATIVE
FDA 510(k)
FDA Class 2
·Immunology
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.·Product code FZP·June 7, 2006
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code FZP·June 15, 2006
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, INC.(CINCINNATI)·Product code FZP·June 8, 2006
LIGACLIP ENDOSCOPIC ROTATING MULTIPLE CLIP APPLIER 20
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC.(CINCINNATI)·Product code FZP·June 7, 2006
ADHESIVE TRACTION TAPE
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GORE-TEX TISSUE MATRIX
FDA 510(k)HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·June 10, 2014
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 11, 2010
ELECTRODE, PACEMAKER, PERMANENT
FDA Adverse Event
Death
·MPRI·Product code DTB·December 10, 2012
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