12 results
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19ms
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Sources: EU EUDAMED, US FDA
E3D-C Interbody System
FDA 510(k)
FDA Class 2
·Orthopedic
Macan
FDA UDI
ACE SURGICAL SUPPLY CO., INC.·00614950029617·ULTRA FLEX BENDABLE ELECTRODE
REDIGUARD IAB CATHETER
FDA Adverse Event
Malfunction
·BARD VASCULAR SYSTEM·Product code DSP·April 22, 1998
UniStrip1 Generic Blood Glucose Test Strips
FDA 510(k)
FDA Class 2
·Clinical Chemistry
SBI RADIO-CAPITELLAR IMPLANT
FDA 510(k)
FDA Class 2
·Orthopedic
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 16, 2014
BIPOL LEAD MODEL 300
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·December 10, 2008
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·August 26, 2011
FENESTRATED BIPOLAR FORCEPSINSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·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 CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 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