29 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033503720·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033503768·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033503775·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134150·Trial, TLIF, 27L OB STR 7Deg, 15mm
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033503744·
Navagio
FDA UDI
Kalitec Direct LLC·B07330K0134110·Trial, TLIF, 27L OB STR 7Deg, 11mm
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033503737·
DESIGN OPTICS
FDA UDI
FGX INTERNATIONAL INC.·00193033503751·
DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
NOVAMETRIX MARQUETTE COMPATIBLE SENSORS
FDA 510(k)
FDA Class 2
·Cardiovascular
0009613348-2024-013451
FDA Adverse Event
Injury
·INSTITUT STRAUMANN AG·Product code DZE·October 8, 2024
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·January 15, 2025
INSET 30
FDA Adverse Event
Malfunction
·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·October 17, 2025
COYOTE¿ ES
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LIT·March 20, 2013
VAPOR WAND
FDA Adverse Event
Malfunction
·DEPUY MITEK INC.·Product code GEI·March 7, 2011
CAPSUREFIX
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·March 10, 2008
DERMATOME BLADES
FDA Adverse Event
Injury
·ZIMMER SURGICAL, INC.·Product code GFD·January 29, 2024
BI-METRIC/X POR NC 16X160
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code LPH·October 2, 2013
M2A 38MM MODULAR HEAD +3MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·October 1, 2013