14 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Mercury® II Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
FlexiNylon cartridges Amhari/Purple Pink
FDA UDI
PERFLEX LTD·07290110500641·box of 6 identical cartridges sealed in aluminu...
APEX PS Knee
FDA UDI
Omni Life Science, Inc.·00841690113744·PS-C Insert, Size 5 x 16mm
FlexiNylon cartridges Amhari/Purple Pink
FDA UDI
PERFLEX LTD·07290110506582·5 identical cartridges sealed in a vacuum bag ;...
MDT Diamond Coated Dental Burs
FDA UDI
M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD.·07291046510742·Rotary FG gold diamond instrument for dental ap...
Ambassador Cervical Plate System
FDA UDI
Choice Spine, LP·00840996161015·AMBASSADOR,DRILL,2.5x16
EMBLETTA MPR
FDA 510(k)
FDA Class 2
·Anesthesiology
ELECSYS PROBNP IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
PEDICLE SCREW MUST MC Ø6X35
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKB·June 13, 2023
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
FDA Adverse Event
Injury
·CORDIS NEUROVASCULAR, INC.·Product code NJE·November 6, 2008
TRIMA ACCEL PLT, PLS, RBC SET
FDA Adverse Event
Malfunction
·CARIDIANBCT·Product code LKN·July 12, 2011
ITREL II
FDA Adverse Event
Malfunction
·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code LGW·July 12, 2013
EXPRESS Dry Seal Chest Drain, Single Collection P/N: 4000-100N
FDA Enforcement
Class II
·Terminated·Atrium Medical Corporation·July 8, 2015
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025