11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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STERI-MATE STERILIZABLE HANDPIECE
FDA 510(k)
FDA Class 2
·Dental
GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
DEPILASE TWIN YAG LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CONTOUR
FDA Adverse Event
Injury
·BAYER HEALTHCARE, LLC·Product code NBW·April 30, 2010
BD BBL¿ TAXO¿ A
FDA Adverse Event
Malfunction
·BECTON DICKINSON CARIBE LTD.·Product code JTO·November 22, 2024
SPRINT QUATTRO
FDA Adverse Event
Injury
·MPRI·Product code LWS·March 27, 2013
ACRYSOF
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·February 18, 2011
LINOX SD 65/16
FDA Adverse Event
BIOTRONIK GMBH AND CO.·Product code LWS·March 19, 2008
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
VesselNavigator application used with Philips Azurion (Azurion 7 Series) Software R1.2 and R2.0, and Philips Allura Xper R9, upgraded to Azurion 1.2 M20. System codes: Azurion 7 B12 (722067), Azurion 3 B20 (722068), Azurion 7 M12 (722078), Azurion 7 M20 (722079), Field Extensions Azurion 7 series (722136), Allura Xper R9 (722303). The product is software, used during an endovascular intervention procedure.
FDA Enforcement
Class II
·Terminated·Philips North America, LLC·February 19, 2020
The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option
FDA Enforcement
Class II
·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018