11 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIPOLAR ELECTROSURGICAL INTRAOCULAR PROBE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
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
SIGMA PEROXIDASE MYELOPEROXIDASE STAINING PROCEDUR
FDA 510(k)
FDA Class 1
·Hematology
GASTROINTESTINAL SHEATH BRUSH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
IFUSE IMPLANT SYSTEM
FDA Adverse Event
Injury
·SI-BONE, INC.·Product code OUR·June 10, 2014
VSTEP REP STD RAD EXP SLV W5-12M VSEALPL
FDA Adverse Event
Malfunction
·USSC PUERTO RICO·Product code GCJ·October 4, 2010
HEARTMATE II LVAD
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·December 6, 2012
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015