7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
FIAX TEST KIT FOR LYME DISEASE ANTIBODIES
FDA 510(k)
FDA Class 2
·Microbiology
STERICAN HYPODERMIC NEEDLES
FDA 510(k)
FDA Class 2
·General Hospital
Magic3 Go Intermittent Urinary Catheter
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ION¿
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·December 13, 2012
SYNERGY
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·October 14, 2010
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·June 13, 2014
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