12 results
·
22ms
·
Sources: EU EUDAMED, US FDA
GORE SPHEREX IMPLANT
FDA 510(k)
FDA Class 2
·Ophthalmic
ADJUSTABLE MULTI-CATHETER SOURCE APPLICTOR
FDA 510(k)
FDA Class 2
·Radiology
TITAN 3-D Wedge System
FDA 510(k)
FDA Class 2
·Orthopedic
PROMUS ELEMENT¿ PLUS
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·February 14, 2013
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 28, 2014
VITALITY 2
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code LWS·January 18, 2011
11.5MM REAMER HEAD FOR RIA 2 STERILE
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTO·June 22, 2020
CONTOUR ACETABULAR RECONSTRUCTION RING
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDJ·June 6, 2025
MESH, SURGICAL, ACETABULAR, HIP, PROSTHESIS
FDA Adverse Event
Injury
·SMITH & NEPHEW, INC.·Product code JDJ·January 23, 2026
HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·March 26, 2025
AHAR50K STANDARD ARTHROSCOPY PACK - 291852. Procedure tray Catalog Number: AHAR50K
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·July 17, 2024
LAPAROSCOPY PACK, Model No. CALS41F, CALS41F-01, CALS41G
FDA Enforcement
Class II
·Ongoing·American Contract Systems Inc·March 26, 2025