8 results
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18ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ULTRA BILI LIGHT
FDA 510(k)
FDA Class 2
·General Hospital
Stainless Steel Tibial Nailing System
FDA UDI
ORTHOFIX SRL·18032568862669·STERILE SOLID TIBIAL NAIL DIAMETER 8 MM LENGTH ...
BACTERIA FILTER
FDA 510(k)
FDA Class 2
·Anesthesiology
MIRACLE EAR MODEL BP BEHIND-THE-EAR HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE
FDA Adverse Event
Death
·THORATEC CORP.·Product code DSQ·February 18, 2013
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·August 4, 2014
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 31, 2011
Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024