22 results
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42ms
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Sources: EU EUDAMED, US FDA
DUAD CO., LTD.
FDA registration
DUAD CO., LTD.·1 product·🇰🇷 South Korea
Yuyao Duode Medical Supplies Co., Ltd.
Manufacturer
🇨🇳 China
NeuViz 16 Multi-Sliced CT Scanner System, part number 989605858501. NeuViz Dual series CT Scanner System, part number 989605651321 The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously.
FDA Recall
Terminated
·Philips And Neusoft Medical Systems Co., Ltd.·Product code JAK·October 18, 2012
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
Skytron Infinity Series surgical light with dual lightheads, 4 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF5454 and IF5454EL.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF2222, IF2222-B, IF2222B/PT, IF2222EL and IN2222EL.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
NeuViz Dual series CT Scanner System, Part number (PN): 989605651321. This is a computed X-ray, Tomography system. NeuViz Dual Multi-slice CT Scanner System 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.·Product code JAK·March 4, 2013
Skytron Infinity Series (also called Astro series) minor surgery light with dual lightheads, 3 bulbs in each of 2 - 19' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN1919 and IN1919EL and IN1919EL/PT.
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22' lighthead and 8 bulbs in 1 - 30' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IF3022B. (note only the 22'' lighthead is affected.)
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN3022EL and IF3022EL. (note only the 22'' lighthead is affected).
FDA Recall
Terminated
·Skytron, Div. The KMW Group, Inc·Product code FTD·January 8, 2007
NeuViz 16 Multi-Slice CT Scanner System, Part number (PN): 989605858501, Model: NeuViz 16. This is a computed X-ray, Tomography system. The NeuViz 16 CT Scanner System can be used as a whole body computed tomography X-ray system featuring a continuously rotating X-ray tube and detector array with multi-slice capability up to 16 slices simultaneously. The acquired X-RAY transmission data is reconstructed by computer into cross-sectional images of the body from the same axial plane taken at different angles. The system is suitable for all patients
FDA Recall
Terminated
·Philips And Neusoft Medical Systems Co., Ltd.·Product code JAK·March 4, 2013
NeuViz Dual series Computed Tomography (CT) Scanner System, X-Ray System. Part Number: 989605651321. 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
·Neuisys, LLC·Product code JAK·July 21, 2008
Clonallon Laboratories Ltd
Importer
3 Manufacturers
Entrhal Medical GmbH
Importer
🇩🇪 Germany·3 Manufacturers
Humiss International B.V.
Authorized representative
🇳🇱 Netherlands·84 Manufacturers·2072 Devices
Medicontur France
Importer
🇫🇷 France·10 Manufacturers
CMC Medical Devices & Drugs SL
Authorized representative
🇪🇸 Spain·698 Manufacturers·11260 Devices
Advena Limited
Authorized representative
🇲🇹 Malta·467 Manufacturers·13717 Devices
KD Surgical Ltd
Importer
🇮🇪 Ireland·20 Manufacturers
Rockmed BV
Importer
🇳🇱 Netherlands·18 Manufacturers