12 results
·
36ms
·
Sources: EU EUDAMED, US FDA
VARELISA CARDIOLIPIN ABS SCREEN
FDA 510(k)
FDA Class 2
·Immunology
LGN PS HIGH FLEX XLPE SZ 1-2 13MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017
GII PS HI FLEX ISRT SZ 7-8 9
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·July 19, 2017
QuadraSphere Microspheres
FDA 510(k)
FDA Class 2
·Cardiovascular
REXEED SERIES DIALYZERS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LGN PS HIGH FLEX XLPE SZ 1-2 13MM
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·August 9, 2017
GII ARTICULAR INSERTER/EXTRACT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018
LINOX SD 65/16
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code LWS·December 13, 2010
OT VERIO TEST STRIPS
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 8, 2013
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 22, 2014
CVS Pharmacy Plastic Sesame Street Adhesive Bandages; a sterile, latex free, assorted sizes with multiple designs adhesive bandages; 20 bandages per box, 24 boxes per case; Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, Made in Egypt; REF CVS 826159, UPC 0 50428 95118 7 The device is used to cover and protect wounds.
FDA Recall
Terminated
·Pharmaplast S.A.E. Free Zone Factory POB 37 Amria Free Zone Kafr El Zayat, Gharbia Egypt·Product code KGX·February 21, 2011
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015