11 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Synapse 3D Base Tools (V7.0)
FDA 510(k)
FDA Class 2
·Radiology
Cascadia™ Interbody System
FDA UDI
VB Spine LLC·10888857370012·Trial, Size 12x14x11 mm, 30°
Nellcor EASYCAP II Adult Colorimetric CO2 Detector, Nellcor PEDCICAP Pediatric Colorimetric CO2 Detector
FDA 510(k)
FDA Class 2
·Anesthesiology
Smith & Nephew ACCORD Cable System
FDA 510(k)
FDA Class 2
·Orthopedic
BD CONNECTA STOPCOCK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·September 24, 2020
CONNECTA PLUS3 RED
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·September 26, 2019
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 29, 2011
VISIAN ICL (IMPLANTABLE COLLAMER LENS)
FDA Adverse Event
Injury
·STAAR SURGICAL COMPANY·Product code MTA·July 23, 2013
BD CONNECTA¿ STOPCOCK
FDA Adverse Event
Malfunction
·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FMG·November 27, 2019
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025