9 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Nunchaku
FDA 510(k)
FDA Unclassified
·Unknown
EMBRACE
FDA 510(k)
FDA Class 2
·Radiology
VNUS CLOSUREFAST CATHETER, MODELS CF7-7-60 AND CF7-7-100
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 8, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 24, 2025
S-ROM M HEAD 36MM +9
FDA Adverse Event
Injury
·1818910 DEPUY ORTHOPAEDICS, INC.·Product code JDI·June 11, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011
PROLIEVE THERMODILITATION KIT
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·September 12, 2008
Jackson-Pratt Silicone Round Drain, 15FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use
FDA Enforcement
Class II
·Terminated·Cardinal Health 200, LLC·May 31, 2017