4 results
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20ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
FDA Enforcement
Class I
·Ongoing·WHILL, INC.·May 6, 2026
WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
FDA Enforcement
Class I
·Ongoing·WHILL, INC.·May 6, 2026
Ami HTX.
FDA Enforcement
Class II
·Ongoing·Spectral Instruments Inc·June 25, 2025
Am I Pregnant? One Step HCG Pregnancy Test REF 100-17
FDA Enforcement
Class II
·Ongoing·Universal Meditech Inc.·November 1, 2023