14 results
·
29ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CELLTRACKS AUTOPREP SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
ArgenZ HT+ 95x30 C4
FDA UDI
ARGEN CORPORATION, THE·D818122821·Dental porcelain/ceramic restoration kit
Zavation
FDA UDI
Zavation LLC·00842166188815·21mm Dilator
22 G X 1.00 IN. (0.9 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 10, 2017
DISCOVRED
FDA 510(k)
FDA Class 2
·Dental
ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 22, 2024
22 G X 1.00 IN. (0.9 MM X 25 MM) BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·October 20, 2017
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 20, 2025
LINOX SD 65/16
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code NVY·May 21, 2013
SELF CENT HIP 46X28 BRN
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC. 1818910·Product code KWY·September 26, 2014
MINICAP
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·June 14, 2011
MINMED QUICK SET
FDA Adverse Event
Malfunction
·UNOMEDICAL UM-D·Product code FPA·February 21, 2025
Folysil Silicone Foley Catheters, Device Reference Numbers AA6106, AA6108, AA6110, AA6112, AA6114, AA6116, AA6118, AA6120, AA6122, AA6124, AA6308, AA6310, AA6312, AA6314, AA6316, AA6318, AA6320, AA6322, AA6324, AA6408, AA6410, AA6412, AA6414, AA6416, AA6418, AA6420, AA6422, AA6424, AA6C18, AA6C20, AA6C22, and AA6C24.
FDA Enforcement
Class II
·Ongoing·Coloplast Manufacturing US, LLC·January 22, 2025