8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
LOOP RETRIEVER
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526159501·PROTECT.EPI ELBOW SUPPORT GRAY II
CAPHOSOL
FDA 510(k)
FDA Unclassified
·Unknown
OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)
FDA 510(k)
FDA Class 2
·Neurology
PENUMBRA ASPIRATION PUMP
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code BTA·March 15, 2010
RESERVOIR
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·May 23, 2014
TECNIS 1 MULTIFOCAL
FDA Adverse Event
Injury
·ABBOTT MEDICAL OPTICS·Product code MFK·November 13, 2012
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