7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
NEBULIZER/HUMIDIFIER
FDA 510(k)
FDA Class 2
·Anesthesiology
GLOW800
FDA 510(k)
FDA Class 2
·Radiology
CFS FLEXIBLE
FDA 510(k)
FDA Class 2
·Dental
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·April 30, 2014
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·October 10, 2012
SHOPRIDER
FDA Adverse Event
Injury
·SHOPRIDER MOBILITY PRODUCTS INC.·Product code ITI·July 22, 2010
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024