3 results
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8ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class Ii
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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