12 results
·
18ms
·
Sources: EU EUDAMED, US FDA
COMBINED END-MULTIPLE LATERAL HOLES EPIDURAL CATHETER (CEMLH EPIDURAL CATHETER)
FDA 510(k)
FDA Class 2
·Anesthesiology
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
Zeta Navigation System (ZNS131-US)
FDA 510(k)
FDA Class 2
·Neurology
TECHLAB ASCA-CHEK
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 ARTICULAR INSERTER/EXTRACT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code MBH·February 9, 2018
SPRINT
FDA Adverse Event
Malfunction
·RICE CREEK MFG·Product code LWS·February 9, 2013
CONTAK RENEWAL
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 7, 2011
MODULAR CATHCART BALL 49MM OD
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code LZY·July 23, 2014
BD BACTEC PEDS PLUS/ F CULTURE VIALS
FDA Adverse Event
Malfunction
·BECTON, DICKINSON & CO. (SPARKS)·Product code MDB·July 14, 2021
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