12 results
·
25ms
·
Sources: EU EUDAMED, US FDA
Paragonix SherpaPak Cardiac Transport System
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Oticon
FDA UDI
Oticon A/S·05707131332899·OPN 3, KIT 312 2.4G NFM L C001
STONE GRASPING BASKET, MODEL PD-T1 2115
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
TAMARIN BLUE PTCA RX DILATATION CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·June 21, 2013
GE OEC 9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·October 3, 2008
8800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 8, 2011
MENTOR CPX4 WITH SUTURE TABS, TALL HEIGHT, SMOOTH
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·October 24, 2019
MENTOR CPX4 WITH SUTURE TABS, MED HEIGHT, SMOOTH
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·January 10, 2020
CPX4 PLUS SMOOTH TALL HEIGHT 550CC
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·April 19, 2022
CPX4 WITH SUTURE TABS MEDIUM HEIGHT SMOOTH EXPANDER
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code LCJ·February 22, 2021
Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024