7 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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AIA-PACK T4
FDA 510(k)
FDA Class 2
·Clinical Chemistry
J1 ATTACHMENT (ORTHODONTIC APPLIANCE)
FDA 510(k)
FDA Class 1
·Dental
BUTTERFLY GLOBE (PATIENT EXAMINATION GLOVE)
FDA 510(k)
FDA Class 1
·General Hospital
INTROCAN SAFETY
FDA Adverse Event
Malfunction
·B. BRAUN MELSUNGEN AG·Product code FOZ·June 4, 2014
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·January 4, 2013
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·November 11, 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