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MDR Video Speech

HYLAND LLC · Model MDR Video Speech · UDI-DI 00850677007075

LMA
10
510(k) clearances
5
Adverse events
2
Recalls
7
Facilities

Description

Speech for the MDR Video

Recalls

DateFirmReason
2019-09-25Brainlab AGThe Brainlab Patient Data Manager software (PDM) in combination with the Brainlab iPlan CMF/Cranial/ENT/Spine software 2.1.1, 2.2.0, 2.2.1, 2.3.0, 2.3.1, 2.4.0, 2.5.0, 2.5.1 (if us
2005-03-30Konica Medical Imaging, Inc.One feature of the software on some of the devices which permits assembling three digital images into one image has occasionally had problems aligning the three images exactly.

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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.