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Head Frame Set for Type 1.1 Systems FDA/ROW

INSIGHTEC LTD · Model SET400168-BD Head Frame Set for Type 1.1 Systems FDA/ROW · UDI-DI 07290019402237

POH Prescription
0
510(k) clearances
261
Adverse events (5 deaths)
0
Recalls
4
Facilities

Description

INSIGHTEC-MADE Head Frame Set for Type 1.1 Systems FDA/ROW. multi use Stereotactic Frame Set for fixing the skull position during neuro FUS clinical treatment

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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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.