8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
DADE IMMU-TRACE TRI-RAC R TRI-LEVEL R.C
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Sphero Attachments
FDA UDI
Preat Corporation·00842092121672·Sphero Block Abutment Hiossen HG Standard x 6mm...
REPROCESSED GUIDEWIRES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
FDA 510(k)
FDA Class 2
·Orthopedic
UNKNOWN DEPUY 3 15MM CVD RP POLY INSERT
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JWH·May 15, 2014
CONCERTO II CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 31, 2012
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·ABBOTT VASCULAR - REDWOOD CITY·Product code MGB·August 16, 2010
Dynamic Locking Screw System (DLS) 3.7mm & Dynamic Locking Screw (DLS) 5.0mm; intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 30, 2015