8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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3M SCOTCHPLATE 51148 SMALL CONDUCTIVE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
Disposable Needle Guides and Grids
FDA 510(k)
FDA Class 2
·Radiology
FT BIPOLAR RESECTION CORD STORZ
FDA Adverse Event
Malfunction
·COVIDIEN LP·Product code GEI·May 1, 2014
HS LONG 5MM CURVED SHEARS
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC (CINCINNATI)·Product code GEI·November 16, 2007
FOUNDATION HIP
FDA Adverse Event
Other
·ENCORE MEDICAL, L.P.·Product code KWY·October 25, 2012
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