8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ACUMED RADIUS ROD
FDA 510(k)
FDA Class 2
·Orthopedic
VIATRONIX V3D VASCULAR, REVISION 1.0
FDA 510(k)
FDA Class 2
·Radiology
Sunny Cup and Applicator
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
INTERSTIM
FDA Adverse Event
Injury
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code EZW·January 29, 2013
SM204 M-SERIES W/BIG WHEEL
FDA Adverse Event
Malfunction
·STRYKER CORP, MEDICAL DIV·Product code FPO·December 2, 2010
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OYC·July 14, 2014
VS3 Iridium Visionsense Infrared (IR) Fluorescence Light Integrator (Beam Combiner) Product Number: 161-0001
FDA Enforcement
Class II
·Ongoing·Visionsense, Ltd.·November 30, 2022
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024