3 results
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8ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Covidien Auto Suture" Blunt Tip Trocar, Product Number OMS-T10BTSNL
FDA Enforcement
Class II
·Ongoing·Covidien, LP·April 10, 2024
OPTICAL BIOMETER AL-Scan: Software Version: 1.09 and earlier. Ophthalmic: The OPTICAL BIOMETER AL-Scan is a measuring device that can measure as a single unit the values necessary to calculate the power of an IOL for cataract surgery such as axial length, corneal curvature radius, and anterior chamber depth. It measures these necessary values successively through a non-contact optical measurement method.
FDA Enforcement
Class II
·Terminated·Nidek Inc·August 24, 2016
DigitalDiagnost C50 1.1-intended for use in generating radiographic images of human anatomy Model Number : 712204
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·April 19, 2023