9 results
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18ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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AD-TECH'S BRAIN BIOPSY NEEDLE FOR STEREOTAXIC
FDA 510(k)
FDA Class 2
·Neurology
Cohere
FDA UDI
Nuvasive, Inc.·00195377000286·COHERE Pivoting Trial, 12x14x34mm 8°
CUI FEATHERED SILICONE MALAR
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MONARCH SPINE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR GALWAY·Product code NIQ·December 7, 2010
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·January 22, 2013
NA
FDA Adverse Event
Injury
·STRYKER SUSTAINABILITY SOLUTIONS PHOENIX·Product code NMJ·July 9, 2014
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