15 results · 21ms · Sources: EU EUDAMED, US FDA

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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