8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
DOBBHOFF(R) PERCUTANEOUS TRANSHEPAT BILIARY STENT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
24PW - Piedmont Natural Gas - Poly White
FDA UDI
Certified Safety Manufacturing, Inc.·00766588130736·24PW - Piedmont Natural Gas - Poly White
IO-TOME DEVICE
FDA 510(k)
FDA Class 2
·Neurology
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS
FDA 510(k)
FDA Class 2
·General Hospital
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 14, 2015
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS, INC.·Product code CBK·January 8, 2013
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 14, 2014
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