11 results
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24ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VALVE, ANTI-SYPHON MODEL PUDENZE FLUSH.
FDA 510(k)
FDA Class 2
·Neurology
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110638·COAXIAL IRR-ASP TIP STR W/SILICONE 0.3MM
Ortho Specialties
FDA UDI
Young Innovations, Inc.·00843471186541·Bicuspid Bands, Upper, Size 2
Ophthalmic Cannula
FDA UDI
KATENA PRODUCTS, INC.·00841668110652·COAXIAL IRR-ASP TIP 45 DEG W/ SILICONE
DIMENSION TACR FLEX REAGENT CARTRIDGE, MODEL DF107
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TEG 6s Hemostasis System
FDA 510(k)
FDA Class 2
·Hematology
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code PAH·September 26, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 19, 2013
PFC SIGMA/RD/DOME PAT 3PEG, 32
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·July 15, 2010
ONX ASCENDING AORTIC 19
FDA Adverse Event
Injury
·ARTIVION, INC. - AUSTIN·Product code LWQ·December 20, 2022
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