9 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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DAND Dental Implant System
FDA 510(k)
FDA Class 2
·Dental
BD
FDA UDI
PRYOR PRODUCTS·00761887000339·6 leg IV stand
BD
FDA UDI
PRYOR PRODUCTS·00761887000346·6 LEG IV STAND STAINLESS STEEL
FREEDOM Integrated Syringe Infusion System
FDA 510(k)
FDA Class 2
·General Hospital
VORTEX EZ VASCULAR ACCESS PORT
FDA 510(k)
FDA Class 2
·General Hospital
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 14, 2014
UNKNOWN DEPUY DURALOC 28X50 10D LINER
FDA Adverse Event
Injury
·DEPUY WARSAW·Product code LPH·September 15, 2011
LIGAMAX-5MM ENDO CLIP APPLIER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code FZP·July 26, 2013
Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
FDA Enforcement
Class II
·Terminated·Boston Scientific CRM Corp·October 23, 2013