4 results
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Sources: EU EUDAMED, US FDA
Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or chronic kidney failure. The system can be used in hospital, health center and outpatient dialysis center settings when prescribed by a Physician. The following types of renal replacement therapy can be carried out with the system: Hemodialysis (HD) with or without phases of pure ultrafiltration, High flux hemodialysis and low flux hemodialysis.
FDA Enforcement
Class I
·Terminated·B Braun Medical Inc·May 11, 2016
Adaptor for Small Battery Drive and Small Battery Drive II. Product Usage: The Light Adaptor for Small Battery Drive (SBD) /Small Battery Drive II (SBD II) is designed for use in traumatology and orthopedic surgery of the skeleton, i.e. drilling, reaming or cutting bone. The Adaptors (05.001.024 and 05.001.108) can be used with one of the electrical consoles belonging to the Electric Pen Drive (EPD) to operate the Small Battery Drive and Small Battery Drive II.
FDA Enforcement
Class I
·Terminated·The Anspach Effort, Inc.·October 5, 2016
Light Adaptor for Small Battery Drive and Small Battery Drive II.
FDA Enforcement
Class I
·Terminated·The Anspach Effort, Inc.·October 5, 2016
EnVeo R Loading System, Model No. LS-EnVeoR-23, LS-EnVeoR-2629, LS-EnVeoR-23-C, LS-EnVeoR-2629-C. Cardiovascular valve delivery system for use with the Medtronic CoreValve Evolut R system.
FDA Enforcement
Class I
·Terminated·Medtronic Cardiovascular Surgery-the Heart Valve Division·August 12, 2015