8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIPAP SYNCHRONY 2
FDA 510(k)
FDA Class 2
·Anesthesiology
DELTA
FDA UDI
Stryker Leibinger GmbH & Co. KG·07613252645054·Delta 2.2mm Panel 3x21 Ctrsinks x 1.4mm
PELVEX HOMETRAINER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
VACUETTE EDTA K2 GEL TUBES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENDURANT II
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·May 3, 2013
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·May 18, 2011
PUMP MMT-722NAP PRDGM INS V2.2 PL EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·July 31, 2008
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015