8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3
FDA 510(k)
FDA Class 2
·Physical Medicine
CSI MANAGED HEALTH SYSTEM MODEL: CSI MODEL 9K
FDA 510(k)
FDA Class 2
·Cardiovascular
BW685, BW685S
FDA 510(k)
FDA Class 2
·General Hospital
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
CONTOUR TS
FDA Adverse Event
Injury
·BAYER HEALTHCARE LLC·Product code NBW·July 8, 2011
SYNCHOMED II
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION·Product code LKK·September 15, 2008
TRANSSEPTAL NEEDLE, BRK SERIES
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code DRC·May 29, 2025
Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. 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