7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
IS-DSDNA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
ADAP-TEMP, MODEL: AT-100
FDA 510(k)
FDA Class 2
·General Hospital
CUSTOMED ANGIODRAPE PACK FEMORAL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS LLC (PR)·Product code NIQ·February 22, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 3, 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