9 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Body Contouring Machine (Models: CS2, CS3, CS5, CS7, CS8, CS11, CS13)
FDA 510(k)
FDA Class 2
·Physical Medicine
GYRUS ACMI URO-EZDILATE URETERAL BALLOON DILATION CATHETER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
FDA 510(k)
FDA Class 2
·Immunology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 11, 2024
COLLEAGUE CXE VOLUMETRICINFUSION PUMP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE·Product code FRN·May 20, 2009
E SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 4, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 2, 2011
SELOX SR 45
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVN·July 17, 2013