5 results
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7ms
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Sources: EU EUDAMED, US FDA
1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" x 15mm OD x 22/15mm ID REF 7 5132 The Westmed Flex Extenders are non invasive, single use/disposable, large bore, corrugated plastic tubes that provide a flexible, low resistance lightweight connection between breathing circuits and patient interface (tracheal tube, tracheostomy tube, or mask).
FDA Enforcement
Class II
·Ongoing·Westmed, Inc.·November 6, 2024
Myelotec Video Guided Catheters, REF 2010 3.0 mm OD x 30 Cm Working Length, Two 1.3mm Working Channels
FDA Enforcement
Class II
·Ongoing·Myelotec, Inc.·August 9, 2017
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
Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
FDA Enforcement
Class II
·Ongoing·Philips Healthcare·December 1, 2021
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
FDA Enforcement
Class II
·Ongoing·On-X Life Technologies, Inc.·May 20, 2026