24 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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CAVERMAP SURGICAL AID
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
ATTENDS HEALTHCARE PRODUCTS
FDA registration
ATTENDS HEALTHCARE PRODUCTS·3 products·🇺🇸 United States
DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EBI ACUMEN SURGICAL NAVIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
CARTO® 3 SYSTEM
FDA Adverse Event
Malfunction
·BIOSENSE WEBSTER, LTD (HAIFA, ISRAEL)·Product code DQK·April 8, 2013
EASYTRAK 2
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code OJX·April 6, 2011
ENDOTAK RELIANCE G
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·May 8, 2008
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code MEB·August 23, 2021
CE INFUSOR LV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·July 14, 2010
CE INFUSOR SV 2, 12 PACK
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·March 10, 2010
DHF 06 HEMOCONCENTRATOR
FDA Adverse Event
Malfunction
·SORIN GROUP ITALY·Product code KDI·May 22, 2025
ZERO TIP
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FFL·February 24, 2025
SENSOR UROLOGICAL GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code EZB·February 25, 2025
UROMAX ULTRA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code EZN·February 25, 2025
SENSOR UROLOGICAL GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code EZB·February 25, 2025
UROMAX ULTRA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code EZN·February 24, 2025
UROMAX ULTRA
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code EZN·February 25, 2025
ZERO TIP
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FFL·February 24, 2025
ZERO TIP
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FFL·February 25, 2025
SENSOR UROLOGICAL GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code EZB·February 25, 2025