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HomeBone Index Finland Oy › Bindex BI-2 Kit

Bindex BI-2 Kit

Bone Index Finland Oy · Model v2 (w/o Gel) · UDI-DI 06430065790044

MUA Prescription
9
510(k) clearances
1
Adverse events
2
Recalls
6
Facilities

Description

Bindex measurement system kit. Packed in a case containing one Bindex BI-2 device and one Bindex Measure BI-41.

Recalls

DateFirmReason
2019-09-03GE Healthcare, LLCCertain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective
2019-09-03GE Healthcare, LLCCertain Achilles Express and Achilles Insight systems were shipped with European CEE-7/7 Type Power Cords to countries where three protruding pin plugs are required for protective

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.