9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BRANEMARK SYSTEM GOLD CYLINDERS AND SCREWS
FDA 510(k)
FDA Class 2
·Dental
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
P-300 CAPNOGRAPH AND PULSE OXIMETER
FDA 510(k)
FDA Class 2
·Cardiovascular
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·January 22, 2013
SM304 M-SERIES W/ZOOM
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIV·Product code INK·November 23, 2010
TENDRIL ST
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC., CRMD·Product code NVN·July 10, 2014
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 9, 2016
ULTRACISION HARMONIC ACE
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code LFL·September 12, 2016
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