14 results
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19ms
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Sources: EU EUDAMED, US FDA
Morph
FDA 510(k)
FDA Class 2
·Radiology
APEX Knee System
FDA UDI
Omni Life Science, Inc.·00841690190943·CHAMFER CUTTING BLOCK SZ 2
LEONE SPA
FDA UDI
LEONE SPA·08033707023562·CALIBRA BANDS 2ND MOLAR n.SLR 32
GL - TAPERED WAFER (25)
FDA UDI
Great Lakes Dental Technologies, Ltd.·D7752600321·GL - TAPERED WAFER (25)
3M™ Unitek™
FDA UDI
3M UNITEK CORPORATION·00652221050045·Lingual Retainer Wire (Bondable) 7 in. Straight...
RT300-S, MODEL FA100052; RT300-SP, MODEL FA100053
FDA 510(k)
FDA Class 2
·Neurology
ReWalk P6.0
FDA 510(k)
FDA Class 2
·Physical Medicine
8F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL·Product code MGB·December 9, 2008
SYNCHROMED II
FDA Adverse Event
Malfunction
·MEDTRONIC NEUROMODULATION·Product code LKK·August 26, 2011
KINETRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·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
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor Bracket Assembly for use with CT and PET/CT systems. Brilliance 16 Power, Brilliance 16/10/6 Water/Air 728240/728245/728246 - Brilliance 16 728255/728256/728266 - Brilliance 6 728250/728251 - Brilliance 10 728260 - Extended Brilliance Workspace
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·July 7, 2021
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