8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PROTECTRODE SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
De Soutter Medical
FDA UDI
DE SOUTTER MEDICAL LIMITED·05051471123045·K-WIRE - DOUBLE TROCAR 0.9mm DIA x 100mm
8000 SERIES VOLUMETRIC PUMP NON-GRAVITY FLOW SET
FDA 510(k)
FDA Class 2
·General Hospital
MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES
FDA 510(k)
FDA Class 2
·Radiology
TRIATHLON CR X3 TIBIAL INSERT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·January 23, 2013
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·November 10, 2010
ISOFLEX OPTIM LEAD
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code DTB·July 10, 2014
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