3 results
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14ms
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Sources: EU EUDAMED, US FDA
Ventralight ST w EchoPS 4"x6" Ellipse- A low profile, bioresorbable, coated, permanent mesh, with a pre-attached removable positioning system, designed for the reconstruction of soft tissue deficiencies during laparoscopic ventral hernia repair. Catalog Number: 5955460G (EU Only)
FDA Enforcement
Class II
·Ongoing·Davol, Inc.·August 2, 2023
Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram.
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Ltd.·December 25, 2024
Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram.
FDA Enforcement
Class II
·Ongoing·Spacelabs Healthcare, Ltd.·December 25, 2024