8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
TL-10 Laparoscopic Scope Cleaner
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TULIP DISPOSABLE CANNULAS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
F&P Evora Nasal Mask Nasal A Model (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack/ SML (Small/Medium/Large) A Model, F&P Evora Nasal Mask Nasal Sleep Lab (Small, Medium, Large, Wide), F&P Evora Nasal Mask Nasal Fit Pack / SML (Small/Medium/Large) Sleep Lab Model
FDA 510(k)
FDA Class 2
·Anesthesiology
PRECISION
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·December 10, 2008
ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code FGE·September 22, 2011
1.6MM THREADED GUIDE WIRE 150MM
FDA Adverse Event
Malfunction
·SYNTHES USA·Product code LRN·August 1, 2013
Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·November 4, 2015
Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 12, 2018