5 results
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15ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Raz-AT (Attendant Tilt) Mobile Shower Commode Chair, Catalog Number Z300 UDI-DI code: (01)00628758003007 Raz-ART (Attendant Rotational Tilt) Mobile Shower Commode Chair, Catalog Number Z333 UDI-DI code: (01)00628758003335 Raz-AT600 (Bariatric Tilt) Mobile Shower Commode Chair, Catalog Number Z360 UDI-DI code: (01)00628758003601 Raz-SP (Self Propel) Mobile Shower Commode Chair, Catalog Number Z200 UDI-DI code: (01)00628758001003 Raz-AP (Attendant Propel) Mobile Shower Commode Chair, Catalog Number Z100 UDI-DI code: (01)00628758001003 The Raz Mobile Shower Commode Chair is intended to be used by people with mobility impairments, who may have difficulty in standing or keeping their balance while completing activities such as showering, toileting, or personal hygiene.
FDA Enforcement
Class II
·Ongoing·Raz Design Inc·March 18, 2026
ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Versions 6.10 and 6.11
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 21, 2021
ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated hematology analyzer Software Versions 6.10 and 6.11
FDA Enforcement
Class II
·Ongoing·Siemens Healthcare Diagnostics, Inc.·April 21, 2021
INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040
FDA Enforcement
Class II
·Ongoing·PHASE SCIENTIFIC INTERNATIONAL LIMITED·January 24, 2024
ViewPoint 6, Model Numbers: a) H47581RJ, b) H47591MA, c) H47591MT, d) H47591PE, e) H47591PR, f) H47591RA, g) H47591SD, h) H47591YA; system, imaging processing, radiological
FDA Enforcement
Class II
·Ongoing·GE Healthcare GmbH·September 25, 2024