12 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PISTON, PLATINUM TEFLON, OTOLOGY IMPLANT
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Ceramill® Liquid
FDA UDI
Amann Girrbach AG·E4947604351·
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110621·COAXIAL VISCOELASTIC ASPIRAT-IRRIGAT TIP
Daytona® Small Stature
FDA UDI
Seaspine Orthopedics Corporation·10889981161781·Laminar Ramped Hook, 5.25 x 5.5mm
TEST, RA, QUANTA-COUNT T-4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TEST, C-REATIVE PROTEIN, LATEX SLIDE
FDA 510(k)
FDA Class 2
·Immunology
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
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·April 10, 2024
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
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025