7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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LIP & CHEEK RETRACTOR
FDA 510(k)
FDA Class 1
·Dental
VALVE FOR CLOSED SYS. URINARY DRAINAGE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DOSE VERIFICATION SYSTEM PATIENT DOSIMETRY SYSTEM, MODEL DVS-I-11: DVS INSERTION TOOL, DVS-D-A: DVS DOSIMETER, DVS-R-100
FDA 510(k)
FDA Class 2
·Radiology
LOCKING SCREW ANCHORAGE Ø3.0MM / L16MM
FDA Adverse Event
Malfunction
·STRYKER TRAUMA SELZACH·Product code HRS·April 24, 2014
KIT 11.5FX19.5 CE MAHURKAR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MSD·September 27, 2012
COGNIS
FDA Adverse Event
Malfunction
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 27, 2010
GE Healthcare, Compact Airway Modules E-CO, E-COV, E-COVX, E-CAiO, E-CAiOV and E-CAiOVX. The Datex-Ohmeda S/5MT Compact Airway Module, E-CAiOVX family is used for monitoring hospital patients respiration, ventilation, and gas exchange status.
FDA Enforcement
Class II
·Terminated·GE Healthcare, LLC·June 25, 2014