7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ALPHATEC WIRE EXTERNAL FIXATION SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
VIVASCOPE SYSTEM, MODEL 1500, 3000
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Gas Module 3
FDA 510(k)
FDA Class 2
·Anesthesiology
INFERIOR END PLATE LARGE-STERILE
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code MJO·February 27, 2013
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·August 5, 2014
INTEGRATED APD SET W/CASSETTE3 PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·February 7, 2011
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