17 results
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31ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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NUVASIVE PRECEPT SPINAL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Logical PX-Series
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215000547·
ENDURANCE
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295016830·ENDURANCE ENDURON ACETABULAR CUP 20 DEGREE 28mm...
HTF PLUS WITH HEPES (HTF WITH NON-ESSENTIAL AMINO ACIDS)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
EVOLVE EPS ORTHOLOC
FDA 510(k)
FDA Class 2
·Orthopedic
QUADRA H FEMORAL STEM SIZE 2 LATERALIZED
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL, SA·Product code MEH·July 30, 2014
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970515·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970522·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973127·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973554·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973011·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172970539·
UniTip High Resolution Catheter
FDA UDI
Unisensor AG·07640172973417·
ULTRA MATTRESS ASSY 4 X 26
FDA Adverse Event
Injury
·STRYKER MEDICAL-KALAMAZOO·Product code FPO·May 21, 2013
10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - CORK·Product code MAV·June 13, 2011
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Malfunction
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·August 18, 2008
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgeries where warm irrigation, slush and/or cold solution are required.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·September 30, 2015