8 results
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20ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ADD-A-CATH
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICROTEK IRRIGATION SYSTEM
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
SLO-FLO 40AL ADJUST-FLOW REGULATOR
FDA 510(k)
FDA Class 1
·Anesthesiology
MINI SPIKE DISP PIN
FDA Adverse Event
Malfunction
·B. BRAUN / B. BRAUN MELSUNGEN AG·Product code LHI·March 4, 2022
SUR-FIT NATURA 2 PC DURAHESIVE MOLDABLE WAFER
FDA Adverse Event
Injury
·CONVATEC INC·Product code EXE·June 9, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code MNI·October 13, 2010
LEVEEN¿ COACCESS¿
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code GEI·December 21, 2012
Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024