6 results
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18ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Affixus¿ Hip Fracture Nail 130¿ 13 mm x 180 mm, Item Number: 814513180
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 19, 2018
XP-CR Tibial Tray - Interlok 63mm Item # 195269
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019
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
FDA Enforcement
Class II
·Ongoing·Philips North America Llc·September 7, 2022
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
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025