BEUDAMED
    27 results · 28ms · 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 ×

    ChemoPlus" Chemo Prep & Admin Kit, CT4025

    FDA Recall
    Terminated ·Cardinal Health 200, LLC·Product code LYU·January 7, 2021

    BlockAid Cut Resistant Surgical Glove Liners, combine stainless steel and synthetic fibers woven together to form a cut resistant glove material. Blockaid Cut Resistant Surgical Glove Liners are to be worn between two layers of surgical gloves. Item Number: 650126, 650127, 650128, 650129, 650130, 650131

    FDA Recall
    Terminated ·Zimmer Biomet, Inc.·Product code LYU·September 11, 2017

    Covidien ChemoPlus Chemo Spill Kit, Nonsterile, SKU DP5108K

    FDA Recall
    Terminated ·Cardinal Health 200, LLC·Product code LYU·January 7, 2021

    CHEMOPLUS DRUG SPILL KIT HOS, SKU CT4004

    FDA Recall
    Terminated ·Cardinal Health 200, LLC·Product code LYU·January 7, 2021

    Kendall Spill Kit, 6 Per Case, NonsterileI, BB6016K

    FDA Recall
    Terminated ·Cardinal Health 200, LLC·Product code LYU·January 7, 2021

    CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K

    FDA Recall
    Terminated ·Cardinal Health 200, LLC·Product code LYU·January 7, 2021

    ChemoPlus Drug Spill Kit-INSTI, SKU DP5016K

    FDA Recall
    Terminated ·Cardinal Health 200, LLC·Product code LYU·January 7, 2021

    CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.

    FDA Enforcement
    Class II ·Terminated·BD Biosciences, Systems & Reagents·January 28, 2015

    CD8 (Leu-2a) PE (In vitro diagnostic), Catalog number 340046. Hematology: Single color direct immunofluorescence reagent for enumerating percentages of mature human suppressor/cytotoxic (CD8+) lymphocytes in erythrocyte-lysed whole blood or peripheral blood mononuclear cell suspensions.

    FDA Recall
    Terminated ·BD Biosciences, Systems & Reagents·Product code GKL·December 19, 2014

    CATH. GUIDE 6F JL3.5 110CM LAU CATHETER LA6JL35A LA 6F 110CM JL35 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL35A

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    CATH. GUIDE 6F JR4.0 110CM LAU CATHETER LA6JR40A LA 6F 110CM JR40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JR40A

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    CATH. GUIDE 6F JR5.0 110CM LAU CATHETER LA6JR50A LA 6F 110CM JR50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JR50A

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    CATH. GUIDE 6F JL4.0 110CM LAU CATHETER LA6JL40A LA 6F 110CM JL40 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number: LA6JL40A

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    CATH. GUIDE 6F JL5.0 110CM LAU CATHETER LA6JL50A LA 6F 110CM JL50 Coronary Guiding catheter designed to provide a pathway through which therapeutic and/or diagnostic devices are introduced into the coronary or peripheral vascular system. Product Number : LA6JL50A

    FDA Recall
    Terminated ·Medtronic, Inc.·Product code DQY·April 5, 2006

    Spectra Optia Apheresis System, REF: 61000, Caridian BCT, Lakewood, CO 80215. A blood component separator used for therapeutic plasma exchanges.

    FDA Recall
    Terminated ·Caridian BCT, Incorporated·Product code LKN·September 21, 2011

    Hermes NC PTA Balloon Dilatation Catheter The balloon dilatation catheter is intended to dilate stenoses in the iliac, femoral, iliofemoral, popliteal, infrapopliteal, and renal arteries, and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent dilatation post-deployment in the peripheral vasculature.

    FDA Recall
    Terminated ·BrosMed Medical Co., Ltd. Bubugaogaofu Lou Lou 15th Songshan Lake Hi Dongguan China·Product code LIT·December 14, 2018

    Stryker Orthopaedics Triathlon femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·May 27, 2015

    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