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Sources: EU EUDAMED, US FDA
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The Spirit TM Select bed is a Med-Surg bed intended to support and transport low to moderate acuity patients in the medical and/or surgical area of the hospital. The Spirit Select bed is also intended for use as a general purpose, variable height hospital bed for general care, post-operative and general medicine wards. The product has a 500 pound safe working load and includes the standard features of an integrated scale and bed exit system, enhanced footboard staff controls for scale and bed exit system and a low bed height of 10.75 inches.
FDA Enforcement
Class II
·Terminated·CHG Hospital Beds Inc·March 23, 2016
Workstation, G2, Configured (P/N 000-0241)
FDA Enforcement
Class II
·Terminated·Intellijoint Surgical, Inc.·August 14, 2019
Zimmer CAS
Manufacturer
🇨🇦 Canada·1 Importer
Change Healthcare Enterprise Viewer
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·May 5, 2021
CARA (Computer Assisted Retinal Analysis), Product ID: +B543CARA0/$$+7V4.7.2/16D202111179
FDA Enforcement
Class II
·Terminated·Diagnos Inc·April 6, 2022
Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·November 15, 2023
Change Healthcare Stratus Imaging PACS 1.4 and Stratus Imaging Share 1.4, a component of Stratus Imaging PACS.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·December 20, 2023
PINPOINT Endoscopic Fluorescence Imaging System
FDA Enforcement
Class II
·Terminated·Novadaq Technologies Inc.·March 9, 2016
Omega Incline Platform Lift
FDA Enforcement
Class II
·Terminated·Savaria Concord Lifts, Inc.·May 3, 2017
The Savaria Stairfriend is a Residential, commercial, indoor, stair lift for curved stairs.
FDA Enforcement
Class II
·Terminated·Savaria Concord Lifts, Inc.·May 3, 2017
Tibial Alignment Guide; Orthopedic Stereotaxic Instrument;
FDA Enforcement
Class II
·Terminated·Zimmer CAS·June 10, 2015
SmartTools Knee System Orthopedic Stereotaxic Instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·April 26, 2017
Horizon Cardiology Hemo. Version 12.2.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
FDA Enforcement
Class II
·Ongoing·Canadian Hospital Specialties Ltd.·July 24, 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
IntelePACS (Image Fusion Module) - InteleViewer
FDA Enforcement
Class II
·Ongoing·INTELERAD MEDICAL SYSTEMS INCORPORATED·March 5, 2025
McKesson Cardiology Hemo. Versions 13.0, 13.1.1, 13.1.2, 13.2, 13.2.1, 14.0.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024
MX-10 surveillance laser system Product Usage: The expected usage of the product is to facilitate observation and surveillance missions from safe standoff ranges.
FDA Enforcement
Class II
·Terminated·Wescam Inc·July 25, 2018
TLC-2000 Therapeutic Medical Laser System, Power Pack component TLC-2002 Used for the temporary relief of knee pain.
FDA Enforcement
Class III
·Terminated·Theralase Inc.·December 11, 2019
Change Healthcare Cardiology Hemo. Versions 14.2, 14.1.1, 14.2, 14.3, 14.3.2, 14.3, 15.0.1, 15.1.
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·October 23, 2024