8 results
·
28ms
·
Sources: EU EUDAMED, US FDA
Milex Incontinence Dish Pessaries; Milex Incontinence Dish Pessaries with Support; Milex Cube Pessaries; Milex Cube Pessaries with Drainage Holes
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
CoLink Sfx Implant System
FDA 510(k)
FDA Class 2
·Orthopedic
LumenR Tissue Retractor System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
VENTAK PRIZM 2 VR
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code LWS·November 11, 2008
GENTLEPOWER LUX CONTRA ANGLE 25LPA
FDA Adverse Event
Malfunction
·KAVO DENTAL GMBH·Product code EFA·September 9, 2011
ENDO GIA
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO HEALTHCARE·Product code GAG·July 24, 2013
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants are intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·March 7, 2018
DELTA XTEND" Reverse Shoulder System Modular Centered and Eccentric Epiphysis Implants intended for use in total shoulder or hemi-shoulder replacement procedures in patients with non-functional rotator cuffs. HA components are for cementless use only.
FDA Enforcement
Class II
·Terminated·DePuy Orthopaedics, Inc.·March 7, 2018