7 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
FDA 510(k)
FDA Class 1
·Microbiology
INTEL HEALTH GUIDE, MODEL: PHS6000
FDA 510(k)
FDA Class 2
·Cardiovascular
Prime Acetabular Cup System
FDA 510(k)
FDA Class 2
·Orthopedic
DELTA
FDA Adverse Event
Death
·DRAEGER MEDICAL SYSTEMS, INC.·Product code MHX·February 21, 2013
ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - FREMONT·Product code DQO·February 7, 2011
ACCESS
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - AIBONITO·Product code FPA·August 5, 2014
Exactech Equinoxe REVERSE SHOULDER,42mm Humeral Liner, a) +0mm, Item number 320-42-00, b) +2.5mm, Item Number 320-42-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024