9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SteriTite Containers System & MediTray Products
FDA 510(k)
FDA Class 2
·General Hospital
DD tempMED
FDA UDI
Dental Direkt GmbH·EDDIK114151·DD tempMED are pre-colored dental milling blank...
MOLLRING MULTITASC
FDA 510(k)
FDA Class 2
·Cardiovascular
THERACLEAR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
FLOGARD
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·July 13, 2011
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTN·June 11, 2013
FLO-GARD 6201 VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE·Product code FRN·September 17, 2008
ANATOMIC
FDA Adverse Event
Malfunction
·AMPLITUDE·Product code JWH·December 11, 2018
Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. 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