8 results
·
21ms
·
Sources: EU EUDAMED, US FDA
CANCELLOUS SCREW WASHER
FDA 510(k)
FDA Class 2
·Orthopedic
UltraScore Focused Force PTA Balloon
FDA 510(k)
FDA Class 2
·Cardiovascular
VITALOGRAPH EC-50 CARBON MONOXIDE MONITOR
FDA 510(k)
FDA Class 2
·Anesthesiology
10MM/130 DEG TI CANN TFNA 170MM - STERILE
FDA Adverse Event
Injury
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HSB·March 30, 2018
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 30, 2014
PROGRAMMING SOFTWARE
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·December 20, 2010
UNKNOWN ZIMMER KNEE IMPLANT
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code JWH·February 13, 2013
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024