8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
OSMOCEL +
FDA 510(k)
FDA Class 1
·Hematology
GAUZE SPONGES
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
EMC-M-180, T3 UPTAKE - 100 TUBES
FDA 510(k)
FDA Class 2
·Clinical Chemistry
INRATIO
FDA Adverse Event
Injury
·ALERE SAN DIEGO, INC.·Product code GJS·March 12, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·November 13, 2012
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP. MEDICAL DIVISION·Product code FNL·September 2, 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
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015