128 results · 20ms · Sources: EU EUDAMED, US FDA

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Rotoprone Therapy System. The Rotoprone Therapy System is an advanced patient care system for the treatment and prevention of pulmonary complications.

FDA Recall
Terminated ·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKZ·December 3, 2014

TriaDyne Proventa Critical Care Therapy System. The TriaDyne Proventa Critical Care Therapy System provides a comprehensive system of pulmonary and skin care therapies for the critically ill, immobilized patient.

FDA Recall
Terminated ·Arjo Hospital Equipment AB HANS MICHELSENSGATAN·Product code IKZ·December 3, 2014

Pausch Uroview FD fluoroscopic X-ray system UDI number (01)04260491620040 Primarily for urological applications (functional X-ray diagnostics, endourology and minimal invasive urology / surgery). The system, which includes a radiologic / urologic treatment table, maybe used for urological treatment, planning and diagnostic procedures, including but not limited to.

FDA Recall
Terminated ·Hans Pausch Rontgengeratebau Gmbh Graf Zeppelin Strasse 1 Erlangen Germany·Product code JAA·March 14, 2017

EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic.

FDA Recall
Terminated ·EMD Chemicals Inc·Product code DNN·March 27, 2008

Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400, IUP-400S, IUP-450, IUP-450S, IUP-500, IUP-550, IUP-600, IUP-600S, IUP-650, IUP-650S, IUP-700, IUP-750, Sterile, Single Use, Utah Medical Products Inc., 7043 South 300 West, Midvale, Utah 84047.

FDA Recall
Terminated ·Utah Medical Products, Inc·Product code HFN·June 16, 2008

EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5

FDA Recall
Terminated ·Hospira, Inc.·Product code DNN·July 26, 2010

NeuViz Dual series computed Tomography Scanner System, X-Ray System The CT scanner is a whole body x-ray computed tomography scanner which features a continuously rotating tube-detector system and functions according to the fan beam principle.

FDA Recall
Terminated ·Philips And Neusoft Medical Systems Co., Ltd. Neusoft Park, Hun Nan Industrial Area Shenyang, Liaoning China·Product code JAK·December 17, 2007

The device is the NeuViz Dual series Computed Tomography (CT) Scanner System. The device is identified as NeuViz Dual, PN: 989605651321. Labeling on the device reads in part: "***Neusoft NeuViz Dual MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD. ADDRESS: NEUSOFT PARK, HUN NAN INDUSTRIAL AREA, SHENYANG 110179, CHINA***". Device is intended to produce cross-section images of head and body by computer reconstruction of x-ray transmission data taken at different angles.

FDA Recall
Terminated ·Philips And Neusoft Medical Systems Co., Ltd. Neusoft Park, Hun Nan Industrial Area Shenyang, Liaoning China·Product code JAK·February 10, 2010