10 results
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20ms
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Sources: EU EUDAMED, US FDA
Lipids
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Valence Robotic Navigation System
FDA UDI
ALPHATEC SPINE, INC.·00190376633497·Straight Spinous Process Clamp, Medium
ceraMotion®
FDA UDI
DENTAURUM GmbH & Co.KG·J011251091200·ceraMotion® Ti Gingival 2, 20 g / dental cerami...
TriVerse Modular Tray Trial
FDA UDI
SIGNATURE ORTHOPAEDICS PTY LTD·09348215098650·
SYNTHOGRAFT
FDA 510(k)
FDA Class 2
·Dental
Vitrea Software Toshiba Package, VSTP-001A
FDA 510(k)
FDA Class 2
·Radiology
TRUERESULT
FDA Adverse Event
Malfunction
·NIPRO DIAGNOSTICS, INC.·Product code NBW·November 5, 2014
INTERSTIM II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·September 8, 2011
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 29, 2013
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21, SZ. N; d) 100-22-22, SZ. P; e) 100-22-23, SZ. R; f) 100-22-24, SZ. S; g) 100-22-25, SZ. T
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·July 10, 2024