8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BASKET FORCEP
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·00842209135646·
OMS SILICONE OIL INJECTOR
FDA 510(k)
FDA Class 3
·Ophthalmic
VENTREZYME, VAST IMMUNOPEROXIDASE ASSAY
FDA 510(k)
FDA Class 2
·Immunology
ENSEAL SUPER JAW
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GEI·June 9, 2014
ATTAIN OTW
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 5, 2010
MEDTRONIC INFUSE BONE GRAFT OR RHBMP2
FDA Adverse Event
Injury
·MEDTRONIC, INC·Product code NEK·November 27, 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