12 results
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11ms
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Sources: EU EUDAMED, US FDA
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A221RT, bone stabilization and fixation
FDA Enforcement
Class II
·Ongoing·Wright Medical Technology, Inc.·May 3, 2023
stryker ORTHOLOC 3Di Fusion Plate MTP Right, REF 58A220RT, bone stabilization and fixation
FDA Enforcement
Class II
·Ongoing·Wright Medical Technology, Inc.·May 3, 2023
CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
FDA Enforcement
Class II
·Ongoing·Terumo Cardiovascular Systems Corporation·July 2, 2025
Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by qualified healthcare professionals.
FDA Enforcement
Class II
·Ongoing·Palodex Group Oy·August 21, 2024
Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
FDA Enforcement
Class II
·Ongoing·Terumo Cardiovascular Systems Corporation·April 9, 2025
One Step K in vitro diagnostic test REF: 81A4
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step 10A in vitro diagnostic test
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step UTI in vitro diagnostic test REF: 3374
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
Uric Acid in vitro diagnostic test REF: 31H0P
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step pH in vitro diagnostic test REF: 31I4P
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
QUCARE Total Cholesterol in vitro diagnostic test REF: 6407
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026
One Step P in vitro diagnostic test REF: 8194
FDA Enforcement
Class II
·Ongoing·DFI Co., Ltd.·May 13, 2026