31 results
·
16ms
·
Sources: EU EUDAMED, US FDA
Filters
Country: Canada
×
e600 Automatic Transport Ventilator, Model Number 01EVE600
FDA Enforcement
Class I
·Terminated·O-Two Medical Technologies, Inc.·April 10, 2019
e500 Automatic Transport Ventilator, Model Number 01EVE500
FDA Enforcement
Class I
·Terminated·O-Two Medical Technologies, Inc.·April 10, 2019
e700 Automatic Transport Ventilator, Model Number 01EVE700
FDA Enforcement
Class I
·Terminated·O-Two Medical Technologies, Inc.·April 10, 2019
Change Healthcare Cardiology Hemodynamics Software
FDA Enforcement
Class II
·Ongoing·CHANGE HEALTHCARE CANADA COMPANY·July 9, 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
SLIM Handle - catalogue #: SLM-HND100 a component of Simple Locking Intramedullary (SLIM) System
FDA Enforcement
Class II
·Terminated·Pega Medical Inc.·August 21, 2019
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 2 MASKS, Item Code 2040
FDA Enforcement
Class II
·Terminated·AMD Medicom Inc.·November 27, 2019
MEDICOM SAFEMASK PREMIER PLUS ASTM LEVEL 3 MASKS, Item Code 2042
FDA Enforcement
Class II
·Terminated·AMD Medicom Inc.·November 27, 2019
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
FDA Enforcement
Class III
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017
ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.
FDA Enforcement
Class II
·Terminated·Baylis Medical Corp *·April 22, 2015
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 3, 2017
Navitrack System - OS Knee Universal, Stereotaxic instrument
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·May 24, 2017
EcoGel 200 - RED Medical Supplies Clear Ultrasound Gel, Model No. 250UG-CMU
FDA Enforcement
Class I
·Ongoing·Red Medical Supplies·October 20, 2021
EcoGel 200 - RED Medical Supplies Blue Ultrasound Gel, Model No. 250UG-BMU
FDA Enforcement
Class I
·Ongoing·Red Medical Supplies·October 20, 2021
EcoGel 100 - RED Medical Supplies Green Ultrasound Gel, Model No. 250UG-GLU
FDA Enforcement
Class I
·Ongoing·Red Medical Supplies·October 20, 2021
Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.
FDA Enforcement
Class II
·Terminated·Laboratoires Bodycad, Inc.·November 24, 2021
Synaptive Trackable Suction Set Standard and Malleable
FDA Enforcement
Class II
·Terminated·Synaptive Medical Inc·July 7, 2021
Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can be folded onto itself for ease of transport after use. This is a retrospective recall report for a removal initiated on 17 June 2008
FDA Enforcement
Class II
·Terminated·Orthosoft, Inc. dba Zimmer CAS·June 14, 2017
PSI Knee System- Prosthesis, knee patellofemorotibial, semi-constrained, cemented, polymer/meal/polymer The Zimmer PSI Knee System is indicated as an orthopedic instrument system to assist in the positioning of knee replacement components.
FDA Enforcement
Class II
·Terminated·Zimmer CAS·December 10, 2014