68 results
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Sources: EU EUDAMED, US FDA
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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
Ritmed Neurological Sponges, Description/REF: 0.5x0.5in, Non-Sterile/55992C; 0.5x1.0in, Non-Sterile/55993C; 0.5x3.0in, Non-Sterile/55994C; 0.75x0.75in, Non-Sterile/55995C; 1.0x1.0in, Non-Sterile/55996C; 1.0x3.0in, Non-Sterile/55997C; 0.5x1.5in, Non-Sterile/55998C
FDA Enforcement
Class II
·Ongoing·AMD Medicom Inc.·June 24, 2026
XLTEK EMU40EX EEG Headbox
FDA Enforcement
Class II
·Terminated·Natus Neurology DBA Excel Tech., Ltd. (XLTEK)·August 8, 2018
DELFI SINGLE USE VARIFIT TOURNIQUET CUFF SINGLE PORT SINGLE BLADDER CONTOUR THIGH CUFF WITH MATHCING LIMP PROTECTION SLEEVE Rx Only, Sterile
FDA Enforcement
Class II
·Terminated·Delfi Medical Innovations, Inc.·May 13, 2020
Delfi Medical Innovations, VariFit Contour Cuffs, single use adult thigh cuff, single port, single bladder, REF 9-9300-003. Rx Only, Sterile
FDA Enforcement
Class II
·Terminated·Delfi Medical Innovations, Inc.·May 13, 2020
Ritmed Neurological Sponges, 0.75x0.75in, Sterile, REF: 85995C
FDA Enforcement
Class II
·Ongoing·AMD Medicom Inc.·June 24, 2026
Snapshot NIR, REF: KD204
FDA Enforcement
Class II
·Ongoing·KENT IMAGING, INC.·January 31, 2024
McKesson Horizon Medical Imaging (HMI) products versions 4.6.1 to including 11.9 and McKesson Radiology (MR) products 12.0 and 12.1.1.
FDA Enforcement
Class II
·Terminated·Mckesson Medical Immaging·March 23, 2016
Various types of Fetal Bovine Serum Bovine sourced Animal Sera for in-vitro diagnostic device and as a growth promoting nutrient in cell culture systems.
FDA Enforcement
Class II
·Terminated·Paa Laboratories Inc·July 24, 2013
Change Healthcare Cardiology Hemodynamics Software
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·July 9, 2025
TLC-2000 Therapeutic Medical Laser System
FDA Enforcement
Class III
·Terminated·Theralase Inc.·March 4, 2020
TLC-2000 Therapeutic Medical Laser System
FDA Enforcement
Class III
·Terminated·Theralase Inc.·March 4, 2020
Change Healthcare Cardiology Hemodynamics software
FDA Enforcement
Class II
·Ongoing·A L I Technologies Ltd·January 22, 2025
Change Healthcare Radiology Solutions software version 14.2.2
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 8, 2025
Change Healthcare Cardiology Hemo Software
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·July 9, 2025
Change Healthcare Radiology Solutions 14.0
FDA Enforcement
Class II
·Terminated·CHANGE HEALTHCARE CANADA COMPANY·October 14, 2020
Change Healthcare Enterprise Viewer
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·May 5, 2021
McKesson Cardiology Hemo software
FDA Enforcement
Class II
·Ongoing·A L I Technologies Ltd·January 22, 2025
Change Healthcare Cardiology Hemo software
FDA Enforcement
Class II
·Ongoing·A L I Technologies Ltd·January 22, 2025
ClearCanvas RIS/PACS
FDA Enforcement
Class II
·Terminated·Synaptive Medical Inc·April 29, 2020