10 results
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27ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SHEA TORP, OTOLOGY IMPLANT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Ceramill® Liquid
FDA UDI
Amann Girrbach AG·E4947604331·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110591·COAXIAL IRRIGAT-ASPIRAT TIP 90 DEG ASP
V-PRO® 1 Plus and V-PRO® maX Low Temperature
FDA 510(k)
FDA Class 2
·General Hospital
DIGITAL RADIOGRAPHY CXDI-50C
FDA 510(k)
FDA Class 2
·Radiology
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 18, 2024
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 21, 2014
GYNECARE MORCELLEX* TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code HET·September 26, 2012
PUMP MMT-722NAS PRDGM INS V2.2 SK EN
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·July 13, 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