7 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TOP DISPOSABLE SPINAL NEEDLE
FDA 510(k)
FDA Class 2
·Anesthesiology
PACING SYSTEM ANALYZER
FDA 510(k)
FDA Class 2
·Cardiovascular
NxStage Therapeutic Plasma Exchange (TPE) Cartridge
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
7900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·March 14, 2014
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·COCHLEAR LTD·Product code MCM·November 22, 2012
2600
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·September 22, 2010
Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024