12 results
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20ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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RE-TRACE URETERAL ACCESS SHEATH, 10/12 FRENCH, LENGTH 35 AND 45 CM, URETERAL ACCESS SHEATH, 12/14 CH-FR, LENGTH 35CM, UR
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
HENRY SCHEIN INC
FDA Adverse Event
Malfunction
·PRIMA DENTAL GROUP·Product code EJL·January 7, 2025
SYNTHES CERVIFIX/ AXON
FDA 510(k)
FDA Class 2
·Orthopedic
CHIENMAX VIETNAM CO. LTD POWDER FREE BLUE NITRILE EXAMINATION GLOVE
FDA 510(k)
FDA Class 1
·General Hospital
INION OTPS BIOABSOBABLE FREEDOMPLATE
FDA Adverse Event
Injury
·INION OY·Product code HRS·November 18, 2014
INION OTPS BIOABSOBABLE FREEDOMPLATE
FDA Adverse Event
Injury
·INION OY·Product code HRS·May 14, 2015
INION OTPS BIOABSORBABLE FREEDOMPLATE
FDA Adverse Event
Injury
·INION OY·Product code HRS·March 19, 2015
HICKMAN TRIFUSION 19CM STRAIGHT KIT WITH INTERMEDIATE KIT
FDA Adverse Event
Malfunction
·C. R. BARD INC. (BASD)·Product code LJS·May 15, 2013
UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·September 26, 2014
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 14, 2011
INION OTPS BIOABSORBABLE FREEDOMPLATE
FDA Adverse Event
Injury
·INION OY·Product code HRS·June 5, 2015
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