11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STRATO PLASTIC PORT INTRO(9 FR)LPS 7513/MODIFIED
FDA 510(k)
FDA Class 2
·General Hospital
ZEPPELIN INSTRUMENTS
FDA 510(k)
FDA Class 1
·Neurology
EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA·Product code NTE·November 23, 2010
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD·Product code MCM·January 10, 2013
2520274-2013-10115
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code KWQ·November 2, 2013
3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral Nailing, Multiloc Humeral Nailing System, Suprapatellar Instrumentation for Expert Tibial Nail, and Adolescent Lateral Femoral Nails (ALFN).
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·June 1, 2016
BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
FDA Recall
Terminated
·Prism Medical Services USA·Product code FSA·May 23, 2013
BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
FDA Recall
Terminated
·Prism Medical Services USA·Product code FSA·May 23, 2013
BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
FDA Recall
Terminated
·Prism Medical Services USA·Product code FSA·May 23, 2013
BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling is used for the transfer of a patient, for example from a bed to a wheelchair.
FDA Recall
Terminated
·Prism Medical Services USA·Product code FSA·May 23, 2013