8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
REVELATION DIAMOND
FDA UDI
Ss White Burs, Inc.·D6909141452·REVELATION DIAMOND FISSUROTOMY NTF-F - 5 PACK
MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131
FDA 510(k)
FDA Class 2
·Orthopedic
HYDRA VISION UROLOGICAL X-RAY SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 14, 2013
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-REDWOOD CITY·Product code MGB·December 3, 2010
UPHOLD? LITE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTP·July 3, 2014
Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 26, 2015