4 results
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7ms
·
Sources: EU EUDAMED, US FDA
AVID TruCustom PV MINOR PACK convenience kits, Item Code: MADN017-02 and MADN017-03
FDA Enforcement
Class II
·Terminated·Avid Medical, Inc.·March 7, 2018
Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.
FDA Enforcement
Class II
·Terminated·Spacelabs Healthcare, Llc·November 20, 2013
MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063
FDA Enforcement
Class II
·Ongoing·Howmedica Osteonics Corp.·October 16, 2024
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021