14 results
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20ms
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Sources: EU EUDAMED, US FDA
KNEE AID
FDA 510(k)
FDA Class 1
·Physical Medicine
Washbon
FDA UDI
ORMCO CORPORATION·00889989042993·LOWER LEFT SECOND MOLAR WASHBON BAND SIZE 2
RIBFIX BLU SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036275297·
RIBFIX BLU SYSTEM
FDA UDI
BIOMET MICROFIXATION, INC·00841036184407·
Automated Perimeter
FDA UDI
OPTOPOL TECHNOLOGY SP Z O O·05903293141137·The PTS 920BY automated projection perimeter is...
MATIRA ANTERIOR CERVICAL SYSTEM
FDA UDI
Kalitec Direct LLC·B07307K0600020·Tray Insert, Level 2
RITRACT SAFETY SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
Piccolo Composite(R) Distal Volar Radius Plate System
FDA 510(k)
FDA Class 2
·Orthopedic
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·September 19, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 18, 2013
CE INFUSOR LV 5, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 16, 2010
Brilliance BigBore Radiology CT - 728244 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. This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·March 29, 2017
Brilliance Big Bore (Radiology) - Model no. 728244, Computed Tomography X-Ray system 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·April 25, 2018
Brilliance Big Bore Radiology CT with 4.2.0 software version. Model #' 728244 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·March 14, 2018