8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
OMKNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
NAR
FDA UDI
NORTH AMERICAN RESCUE, LLC·10842209135100·
SCLERAL SPONGE II, OLK DESIGN, E5395-10 & E5395-11
FDA 510(k)
FDA Class 2
·Ophthalmic
SIMPSON OBSTETRICAL FORCEPS-SS TYPE 410 OR 420
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
ITOTAL G2
FDA Adverse Event
Injury
·CONFORMIS·Product code JWH·May 28, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 5, 2010
PROXIMATE PPH PROCEDURE SET
FDA Adverse Event
Malfunction
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·December 3, 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