7 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ANA TRANS TUBE & SWABS STERILE PACK
FDA 510(k)
FDA Class 1
·Microbiology
RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E
FDA 510(k)
FDA Class 2
·Immunology
BOUNDARY HEADWEAR
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 28, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·November 15, 2012
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MPRI·Product code DTB·June 10, 2015
ELLIPSE DR, Tiered-therapy cardioverter/defibrillator, REF: CD2411-36Q, UDI: 05414734507615
FDA Enforcement
Class I
·Terminated·St Jude Medical Inc.·August 14, 2019