13 results
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33ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LITHOSKOP
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SOLIDEA
FDA UDI
CALZIFICIO PINELLI SRL·08300496070665·BE YOU TONIC CURVY, SIZE M-XL, CHAMPAGNE, GRADU...
PILLING
FDA UDI
TELEFLEX INCORPORATED·24026704507591·
TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER
FDA 510(k)
FDA Class 2
·General Hospital
TRANSAMERICA DIGITAL EMS
FDA 510(k)
FDA Class 2
·Physical Medicine
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 25, 2024
ACCU-CHEK ® SPIRIT COMBO
FDA Adverse Event
Injury
·ROCHE DIABETES CARE AG·Product code LZG·April 22, 2013
ARCHITECT TOTAL B-HCG
FDA Adverse Event
Malfunction
·A.I.D.D LONGFORD·Product code DHA·April 27, 2011
CONTOUR CURVED CUTTER STAPLER
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC·Product code GDW·July 1, 2008
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012
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