3 results
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8ms
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Sources: EU EUDAMED, US FDA
Flexible Smoothbore Breathing Circuit with Exhalation Port 22mm, Product No. 80062000
FDA Enforcement
Class II
·Terminated·Intersurgical Inc·July 4, 2018
Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic use for evaluating the ADVIA Centaur CKMB assay. This material is intended to be run singly as unknown samples after a two-point calibration has been performed on the system.
FDA Enforcement
Class II
·Terminated·Siemens Healthcare Diagnostics, Inc·October 24, 2018
Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic
FDA Enforcement
Class II
·Ongoing·B-K Medical A/S·November 12, 2025