8 results
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31ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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UROSTYM BIOFEEDBACK AND STIMULATION ANAL/RECTAL PROBES
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
LORI-MODEL O, LOW PROFILE IN-THE EAR INSTRUMENT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
COSP2
FDA 510(k)
FDA Unclassified
·Unknown
METRX SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 10, 2024
OT VERIO PRO METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 7, 2013
NEXGEN CR-FLEX FEMORAL COMPONENT POROUS
FDA Adverse Event
Malfunction
·ZIMMER, INC.·Product code HSA·January 13, 2011
ATTAIN ABILITY PLUS
FDA Adverse Event
Injury
·MPRI·Product code OJX·August 8, 2014
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