8 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
C.A.R.E. Appliance (DNA, mRNA, mmRNA)
FDA 510(k)
FDA Class 2
·Dental
FINGERTIP PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HIP IMPLANT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDH·February 16, 2019
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 6, 2014
INRATIO2
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code GJS·July 20, 2011
SCREWDRIVER, LONG T2 TIBIA 3,5 MM
FDA Adverse Event
Malfunction
·STRYKER OSTEOSYNTHESIS-KIEL·Product code LXH·July 17, 2013
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018