13 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PARAGOLFER
FDA 510(k)
FDA Class 2
·Physical Medicine
Mini-Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR70609361·Mini Sprint-Brackets Roth .022" 20 Brackets 3-5...
VAPR 2.3MM WEDGE ELECTRODE FOR USE WITH VAPR SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODIFICATION TO SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
SAVVY PTA DILATATION CATHETER
FDA Adverse Event
Malfunction
·CORDIS DE MEXICO·Product code LIT·April 16, 2013
ELECTRIC POSITIONING CHAIR
FDA Adverse Event
Malfunction
·CHAMPION MANUFACTURING·Product code INO·January 20, 2011
VECTRA GENISYS
FDA Adverse Event
Other
·CHATTANOOGA GROUP·Product code IPF·June 11, 2008
PROLIFT PELVIC FLOOR REPAIR
FDA Adverse Event
Injury
·ETHICON, INC.·Product code OTP·October 4, 2012
Brilliance iCT SP Computed Tomography X-Ray System, 510 (k) #K060937, Model #728311, Serial Numbers: 200005, 200013, and 200047. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy 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 analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011
Brilliance iCT Computed Tomography X-Ray System, 510 (k) #K060937, Model #728306, Serial Numbers: 100019, 100023, 100087, 100103, and 100170. The recalled system units are equipped with operating software version; 3.2.0.19011. The Brilliance ICT and Brilliance ICT SP are Computed Tomo grapy 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 analysis and display equipment, patient, and equipment supports, components and accessories.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code JAK·June 15, 2011
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022
The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·September 7, 2022