8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
SONOLAYER-L, SAL-77A
FDA 510(k)
FDA Class 2
·Radiology
LEONE SPA
FDA UDI
LEONE SPA·08033707030799·WEB 1ST MOL BANDS W/G8325-02 KIT UR
SPLASH! IMPRESSION MATERIAL DEVICE
FDA 510(k)
FDA Class 2
·Dental
Reprocessed Steerable Introducer
FDA 510(k)
FDA Class 2
·Cardiovascular
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 5, 2014
EX-PRESS MINI GLAUCOMA SHUNT
FDA Adverse Event
Malfunction
·OPTONOL, LTD·Product code KYF·November 14, 2012
S-ROM SLEEVE PRX ZTT, 16D-SML
FDA Adverse Event
Malfunction
·DEPUY INTL LTD·Product code LPH·September 28, 2010
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022