15 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
ENDOMAXX FULLY COVERED ESOPHAGEAL STENT
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213026186·microSelectron Transfer Tube for 4F Flexible (29)
Specials
FDA UDI
Seaspine Orthopedics Corporation·10889981319793·16x14x11 Trial Rasp, w/ Depth Stop
RELAY POWER WHEELCHAIR
FDA 510(k)
FDA Class 2
·Physical Medicine
CARDIOCAM MODEL 9CSY0799
FDA 510(k)
FDA Class 2
·Radiology
Ascendant
FDA UDI
Choice Spine, LP·10885862260833·
JRNY BCS PAT RESRF RD 35 MM STD
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·August 30, 2017
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE GMBH·Product code NBW·May 14, 2013
ARTICULEZE M HEAD 36MM +1.5
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·May 13, 2011
ORTHO PROVUE
FDA Adverse Event
Malfunction
·MICRO TYPING SYSTEMS, INC.·Product code KSZ·August 13, 2008
JOURNEY POLY TIBIAL INSERT
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·June 12, 2017
PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JWH·October 15, 2025
DuraGen Plus Dural Regeneration Matrix DuraGen Plus Adhesion Barrier Matrix is an absorbable implant for repair and restoration of dural defects and as an adhesion barrier for the reduction of peridural fibrosis. DuraGen Plus matrix is an easy to handle, soft, white pliable, non-friable, porous, collagen matrix. DuraGen Plus matrix is supplied sterile, nonpyrogenic, for single use in double peel packages in a variety of sizes.
FDA Enforcement
Class II
·Terminated·Integra LifeSciences Corporation·May 22, 2013
EMBLEM S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A209
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021
ACCOLADE DR EL MRI (Model L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025