7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
SURVIVAL KIT, INDIVIDUAL, TROP, TACTICAL AIR CREW
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
INFUSION ACCELERATOR
FDA 510(k)
FDA Class 1
·General Hospital
MAYFIELD RADIOLUCENT DISPOSABLE SKULL PINS
FDA 510(k)
FDA Class 2
·Neurology
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HLTHCARE CORP·Product code FRN·January 29, 2014
VITALITY 2
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 15, 2010
PENTA
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 5, 2012
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