11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112977·CORNEAL TREPHINE BLADE9.0MM
TPRLC 133 MP TYPE1 PPS SO 13.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·May 31, 2018
Flexible Cystoscope (Model: CY50H-20EU, CY50H-20US, CY55H-24EU, CY55H-24US)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY
FDA 510(k)
FDA Class 2
·Microbiology
TPRLC 133 MP TYPE1 PPS SO 10.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·May 31, 2018
TPRLC 133 MP TYPE1 PPS SO 10.0
FDA Adverse Event
Malfunction
·ZIMMER BIOMET, INC.·Product code KWA·May 31, 2018
6F ANGIO-SEAL VASCULAR CLOSURE DEVICE VIP
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, PUERTO RICO, B.V.·Product code MGB·November 14, 2008
UNICEL® DXC 800 SYNCHRON® CHEMISTRY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·September 2, 2011
URETEX SUPPORT PP KIT X1
FDA Adverse Event
Injury
·SOFRADIM PRODUCTION·Product code OTN·July 8, 2013
TRUE METRIX
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·November 11, 2024