8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
UNIVERSAL WRIST SPLINT & FOREARM SPLINT
FDA 510(k)
FDA Class 1
·Physical Medicine
Ablacath Mapping Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
RUSCH GUIDED CHOLANGIOGRAPHY CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT
FDA Adverse Event
Malfunction
·DENTSPLY PROFESSIONAL·Product code EKX·February 28, 2014
S-ICD SYSTEM
FDA Adverse Event
Injury
·CAMERON HEALTH INC.·Product code NVY·June 4, 2015
ACCURUS 400VS
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·August 27, 2010
Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number: EG-111 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water - in some cases small quantities of disinfectant solutions - for dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024
Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Number: EG-1000 Software Version: N/A Product Description: CLEANER bottles used with EMS AIRFLOW PROPHYLAXIS MASTER / EMS AIRFLOW ONE devices to clean the water lines. The bottle is placed on the device during cleaning. Component: YES. AIRFLOW PROPHYLAXIS MASTER and AIRFLOW PROPHYLAXIS ONE
FDA Enforcement
Class II
·Ongoing·Electro Medical Systems SA·May 1, 2024