12 results · 23ms · Sources: EU EUDAMED, US FDA

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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