12 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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FX-CABLELOK SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
InnerVue II 100mm Scope Kit
FDA UDI
BIOVISION TECHNOLOGIES, LLC·00851582006085·1.2mm Disposable InnerVue II Scope with Accesso...
BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025
BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025
BLOOD COLLECTION TUBES
FDA Adverse Event
Malfunction
·TRI-TECH FORENSICS, INC.·Product code JKA·July 29, 2025
BR SLA Type Implant System
FDA 510(k)
FDA Class 2
·Dental
GLOOKO LOGBOOK CHARTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HUDSON NEONATAL CIRCUIT W/DUAL WATER TRAP
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code BZO·January 15, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·December 13, 2010
ACTIVA
FDA Adverse Event
Death
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 9, 2014
RUNWAY GUIDE CATHETER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·May 8, 2013
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