6 results
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7ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Iii
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Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
FDA Enforcement
Class III
·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026
Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
FDA Enforcement
Class III
·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026
Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
FDA Enforcement
Class III
·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026
Surepulse VS Cap Extra Small REF: SP-159-A1 component of VS Newborn Heart Rate Monitor
FDA Enforcement
Class III
·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026
Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
FDA Enforcement
Class III
·Ongoing·SUREPULSE MEDICAL LTD·February 18, 2026
AutoDELFIA Neonatal immunoreactive trypsin(ogen) (IRT) kit, intended for the quantitative determination of human immunoreactive trypsin(ogen) (IRT) in blood specimens. (UDI: (01)06438147298716(17)190430(10)656479); Product Number: B005-212
FDA Enforcement
Class III
·Terminated·PerkinElmer Life and Analytical Sciences, Wallac, OY·September 12, 2018