12 results
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23ms
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Sources: EU EUDAMED, US FDA
BI-CENTRIC SYSTEM
FDA 510(k)
FDA Class 1
·Dental
Ceramill PEEK by JUVORA™ Oyster White
FDA UDI
JUVORA LIMITED·05055948229315·CERAMILL PEEK by JUVORA™ 760404, Oyster White 9...
The Orthodontic Store
FDA UDI
Young Innovations, Inc.·00843471179451·Anatomical Molar Bands, Lower Right 1St Molars,...
AG-PLUS, MODEL 91210
FDA 510(k)
FDA Class 2
·Anesthesiology
SYRINGE, DISPOSABLE, ALL PLASTIC
FDA 510(k)
FDA Class 2
·General Hospital
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 21, 2014
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·September 26, 2012
ACTICON NEOSPHINCTER
FDA Adverse Event
Injury
·AMERICAN MEDICAL SYSTEMS, INC.·Product code MIP·July 12, 2010
Pressure Monitoring Set, Single-lumen uncoated central venous catheter. RPN C-PMS-250, GPN G02838
FDA Enforcement
Class II
·Completed·Cook Incorporated·July 20, 2022
CAPNOCHECK BCI Airway Adapter; Model Number BSR; Product Code WW8214
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·March 26, 2025
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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