9 results
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20ms
·
Sources: EU EUDAMED, US FDA
INNOVISION-DXII
FDA 510(k)
FDA Class 2
·Radiology
Darby Dental Supply, LLC
FDA UDI
DARBY DENTAL SUPPLY, LLC·00889813035603·Reamers With Silicone Stops 25MM #15
Universal Abutment
FDA UDI
BICON, LLC·00813110029386·Universal Abutment UA5 SP 0° - 2.5mm Tall Post
REDAPT Porous Acetabular Shell and Cemented Liner
FDA 510(k)
FDA Class 2
·Orthopedic
SPOTCHEM II LDH TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
REALIZE ADJ GASTRIC BAND STR
FDA Adverse Event
Malfunction
·OBTECH MEDICAL SARL·Product code LTI·December 2, 2008
BD VACUTAINER
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO·Product code JKA·September 6, 2011
DA VINCI SI SURGICAL SYSTEM
FDA Adverse Event
Death
·INTUITIVE SURGICAL,INC.·Product code NAY·July 29, 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