10 results
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18ms
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Sources: EU EUDAMED, US FDA
SECA DIGITAL BABY SCALE 727
FDA 510(k)
FDA Class 1
·General Hospital
Stradis Healthcare
FDA UDI
STRADIS MEDICAL, LLC·M7526822135·General Surgical Kit
Partial Pelvis Replacement
FDA UDI
WALDEMAR LINK GmbH & Co. KG·04026575048670·Fixation Screw,for obturator foramen hook, incl...
Kyocera Medical Technologies, Inc.
FDA UDI
KYOCERA MEDICAL TECHNOLOGIES, INC.·00841523103249·Tapered Femoral Stem, Lateral Offset, Right Ant...
TESTOSTERONE RADIOIMMUNOASSY KIT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
URETERAL ACCESS SHEATH SET (UASS)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·May 20, 2014
PULSAR GENERATOR
FDA Adverse Event
Malfunction
·MEDTRONIC ADVANCED ENERGY LLC·Product code GEI·October 25, 2012
AVALON ELITE
FDA Adverse Event
Death
·AVALON LABORATORIES LLC·Product code DWF·August 26, 2010
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