14 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SOMATOM Drive
FDA 510(k)
FDA Class 2
·Radiology
INFINION CX
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 17, 2020
CARDIOIMMUNE XL CARDIAC MARKER CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ACCU-CHEK ULTRFLEX INFUSION SET
FDA 510(k)
FDA Class 2
·General Hospital
SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Malfunction
·COOK INC·Product code LJS·December 19, 2017
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·March 31, 2020
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·July 8, 2011
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
VECTRA GENISYS 4CH COMBO
FDA Adverse Event
Injury
·CHATTANOOGA GROUP·Product code IMG·September 15, 2008
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·May 26, 2022
ARTOURA BREAST TISSUE EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·October 10, 2020
TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Injury
·COOK INC·Product code LJS·October 1, 2018
TURBO-FLO SINGLE LUMEN CENTRAL VENOUS CATHETER SET
FDA Adverse Event
Injury
·COOK INC·Product code LJS·October 1, 2018
Jackson-Pratt Hemaduct Silicone Round Drain, 15FR W/15FR Trocar. 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