8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CORALENT COAT 125I CORTISOL RADIOIMM.
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Elevator
FDA UDI
KATENA PRODUCTS, INC.·00841668108574·JOSEPH PERIOSTEAL ELEVATOR
INORGANIC PHOSPHORUS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CREO Stabilization System, Navigation Instruments, ExcelsiusGPS Instruments
FDA 510(k)
FDA Class 2
·Orthopedic
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 6, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·October 15, 2012
SPECIALITE
FDA Adverse Event
Malfunction
·HILL ROM·Product code KZF·August 3, 2010
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024