BEUDAMED
    129 results · 21ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Terminated ×

    NDC, Inc. Pro Advantage Urine Analyzer, Catalog Number: Pro Advantage Urine Analyzer The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.

    FDA Recall
    Terminated ·Teco Diagnostics·Product code KQO·October 1, 2010

    Henry Schein, Inc. OneStep Pro Urine Analyzer, Catalog Number: OneStep Pro Urine Analyzer The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.

    FDA Recall
    Terminated ·Teco Diagnostics·Product code KQO·October 1, 2010

    Cliawaived, Inc. CLIA-101 Urine Analyzer, Catalog Number: CLIA-101 The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.

    FDA Recall
    Terminated ·Teco Diagnostics·Product code KQO·October 1, 2010

    Cole Taylor Marketing, Inc. CT-101 Urine Analyzer, Catalog Number: CT-101 The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.

    FDA Recall
    Terminated ·Teco Diagnostics·Product code KQO·October 1, 2010

    Immunostics, Inc. Detector UriStrip Urine Analyzer, Catalog Number: Detector UriStrip Urine Analyzer The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.

    FDA Recall
    Terminated ·Teco Diagnostics·Product code KQO·October 1, 2010

    McKesson Medical Surgical 107-101 Urine Analyzer, Catalog Number: 107-101 The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.

    FDA Recall
    Terminated ·Teco Diagnostics·Product code KQO·October 1, 2010

    Teco Diagnostics Uritek TC-101 Urine Analyzer, Catalog Number: TC-101 The Uritek TC-101 (TC-101) urine chemistry analyzer is a semi-automated analyzer for urine chemistry analysis. This device has been manufactured and developed with advanced scientific technology of modern microprocessors, optics and electronics. The apparatus uses advanced testing technology of a cold-light source, integrating sphere, and modularized blocking systematical design which enhances the stability of the optical system. This system also automatically compensates for the influence of ambient and scattered lights through the coordination of software and hardware. The TC-101 can test for 10 parameters including Glucose (GLU), Urobilinogen (URO), Bilirubin (BIL), Ketone (KET), Specific Gravity (SG), Occult Blood (BLD), pH, Protein (PRO), Nitrite (NIT), Leukocytes (LEU) in 60 seconds when used with Urine Reagent Strips (URS) 10.

    FDA Recall
    Terminated ·Teco Diagnostics·Product code KQO·October 1, 2010

    Cardinal Health Jackson-Pratt Channel Drain 15FR, Full flutes, with trocar Product Number: JP-2189 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code GBX·June 28, 2019

    Temperature sensing catheter 14FR, Catalogue Number 102201101463NU Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018

    Thermistor Foley catheter, nonsterile, Catalogue Number 102201101663MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018

    Temperature Sensor Catheter 8FR, Catalogue Number 102201100863BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018

    Temperature sensing catheter 16FR, Catalogue Number 102203101663DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018

    Temperature Sensor Catheter 12FR, Catalogue Number 102201101263BI Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018

    Cardinal Health Jackson-Pratt Channel Drain 19FR, Full flutes, with trocar Cardinal Health: PN: JP-2191 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain fluids from body cavities, or evaluate certain physiologic conditions.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code GBX·June 28, 2019

    Temperature sensor Foley catheter 8FR, Catalogue Number 102205100880AB Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018

    Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code GBX·January 31, 2017

    Temperature sensing catheter 18FR, Catalogue Number 102203101863DO Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018

    Foley Catheter with temperature sensor 400TM 18FR, Catalogue Number 102201101880TY Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018

    Temperature Sensing 100% Silicone Foley Catheter, sterile, Catalogue Number 102201101680MD Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018

    Foley Temperature Sensor Catheter 12FR, Catalogue Number 102201101280JP Product Usage: This is sterile, single use, two-way silicone Foley Catheter with a thermistor embedded in the third lumen. It is intended for use in the drainage/ collection of urine from the urinary bladder and simultaneous monitoring of the body core temperature during surgery or post-surgical period.

    FDA Recall
    Terminated ·Degania Silicone, Ltd. Degania Bet Dganya Bet Israel·Product code EZL·June 21, 2018