12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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EASE (MODIFICATION TO)
FDA 510(k)
FDA Class 2
·Dental
SW
FDA UDI
SW SAFETY SOLUTIONS INC.·00616489125532·PowerChem Neoprene Exam Gloves, Medium
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77714031·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77714030101·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77714031001·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
Micro Sprint®
FDA UDI
Forestadent Bernhard Förster GmbH·EFOR77714030051·Micro Sprint Bracket McLaugh/Benn/Trev. .018" m...
OralTox Oral Fluid Drug Test
FDA 510(k)
FDA Class 2
·Clinical Toxicology
X3C 1600 DIGITAL RADIOGRAPHIC SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
VALIANT CAPTIVIA
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·April 24, 2014
ASR ACETABULAR IMPLANT 56
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KWA·October 4, 2012
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·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