BEUDAMED
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    Sydney IVF Culture Oil, REF, K- SICO- 50, 50 mL. and K-SICO-200, 200 mL,Store at 2-8 C, Sterile, Cook Medical, William A Cook Australia LTD, Product Usage: Culture oil is intended to be used as an oil overlay for cultures of gametes, zygotes, or embryos in assisted reproductive technology (ART) and micro manipulation procedures. It is used to reduce the osmotic stress due to evaporation and to reduce pH fluctuations.

    FDA Recall
    Terminated ·Cook, Inc.·Product code MQL·February 15, 2012

    STERRAD NX Sterilization System Product Code 10033 The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MLR·March 9, 2009

    STERRAD 50 Sterilization System Product Code 10050 The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code FLF·March 9, 2009

    Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·March 23, 2016

    Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stretcher

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·March 23, 2016

    Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil

    FDA Enforcement
    Class II ·Terminated·Rainbow Specialty & Health Products·December 30, 2015

    Transport Stretcher, and Head and Neck Surgery Stretcher Non-powered stretcher

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code FPO·February 5, 2016

    Prime Series Stretchers (Fifth Wheel, Big Wheel and Zoom) Powered stretcher

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code INK·February 5, 2016

    Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingredients: Eugenol Oil

    FDA Recall
    Terminated ·Rainbow Specialty & Health Products·Product code GDY·November 18, 2015

    STERRAD 200 Sterilizer (Single Door), Part Number: 10201. STERRAD 200 Sterilizer (Double Door), Part Number: 10202. The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.

    FDA Recall
    Terminated ·Advanced Sterilization Products·Product code MLR·September 18, 2013

    NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".

    FDA Enforcement
    Class II ·Terminated·Philips And Neusoft Medical Systems Co., Ltd.·August 1, 2012

    GE Discovery VCT, Volume PET-CT scanner, Model 5124069-3.

    FDA Recall
    Terminated ·GE Healthcare·Product code JAK·December 21, 2006

    GE LightSpeed VCT Select / LightSpeed Pro32, Model 5126093, CT Scanner system.

    FDA Recall
    Terminated ·GE Healthcare·Product code JAK·December 21, 2006

    NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system, and has a Part number 989605858501. The device is labeled in part: "***Neusoft***NeuViz16 MULTI-SLICE CT SCANNER SYSTEM***MANUFACTURED FOR NEUSOFT MEDICAL SYSTEMS CO., LTD***MANUFACTURED BY PHILIPS AND NEUSOFT MEDICAL SYSTEMS CO., LTD***ADDRESS: NEUSOFT PARK, HUNNAN INDUSTRIAL AREA, SHENYANG***CHINA***".

    FDA Recall
    Terminated ·Philips And Neusoft Medical Systems Co., Ltd.·Product code JAK·June 8, 2012

    GE LightSpeed VCT / Light Speed VCT standard configuration, Model 5124069, CT Scanner System.

    FDA Recall
    Terminated ·GE Healthcare·Product code JAK·December 21, 2006

    GE LightSpeed Xtra / GE LightSpeed RT Pro 16, Model 2374681-6, CT Scanner systems.

    FDA Recall
    Terminated ·GE Healthcare·Product code JAK·December 21, 2006

    MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·September 26, 2012

    GE LightSpeed Pro 16 (100kW/80kW) Models 2357739, 2357739-3, 2357739-4, 2357739-6, 2357739-7 and 2357739-8, CT Scanner systems

    FDA Recall
    Terminated ·GE Healthcare·Product code JAK·December 21, 2006

    MX 16-slice CT Scanner System, models 728131 and 728132. The MX 16-slice CT Scanner System can be used as a whole body computed tomography X-ray system.

    FDA Recall
    Terminated ·Philips Medical Systems (Cleveland) Inc·Product code JAK·August 24, 2012

    GE, VCT for Discovery VCT, Discovery RX VCT, and Discovery PET/CT 690, Lightspeed VCT, Discovery CT750HD. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code JAK·July 25, 2011