BEUDAMED
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    TVS LPA, Catalog #: DIL-059-00

    FDA Enforcement
    Class II ·Terminated·Galt Medical Corporation·August 8, 2018

    1) TVS LPA, Sterile EO, Rx Only, Catalog #: a) KIT-071-01; b) KIT-071-03; c) KIT-071-10; d) KIT-071-11; 2) Enhance Transcarotid/Peripheral Access Kit, Sterile EO, Rx Only, Catalog #: a) KIT-075-02; b) KIT-075-03

    FDA Enforcement
    Class II ·Terminated·Galt Medical Corporation·August 8, 2018

    Evolve Cell Culture Bags, part numbers: EV1000N and EV3000N The Evolve bag is made of Ethyl Vinyl Olefin (EVO) and contains no BPA or latex. The bag can be supplied with tubing sets that can include, but are not limited to, the following components: EVA/PVC coextruded tubing, PVC tubing, Yconnectors, needle-free valves, female luers, male luers and/or caps

    FDA Enforcement
    Class III ·Terminated·OriGen Biomedical, Inc.·April 21, 2021

    MEGA¿ 7.5Fr. 30cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 7.5Fr. 40cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ MEGA¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit, STATLOCK¿ & APA

    FDA Enforcement
    Class II ·Terminated·Datascope Corporation·June 15, 2016

    REF 4890 SMARTSCRAPER CE0123, STERILE EO. Used in oral surgery.

    FDA Enforcement
    Class II ·Terminated·Meta C.G.M. Spa·June 9, 2021

    REF: 3598 SAFESCRAPER TWIST, CE 0123, STERILE EO. Used in oral surgery.

    FDA Enforcement
    Class II ·Terminated·Meta C.G.M. Spa·June 9, 2021

    Sentinel MULTIGENT Ammonia Ultra Reagent, In-Vitro Diagnostic for ammonia measurement; List Number: LN 6K89-30. Intended for the in vitro quantitative determination of Ammonia (NH3) in human plasma.

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·November 4, 2015

    MULTIGENT Creatinine (Enzymatic), Catalog Numbers 8L24-31 and 8L24-41; IVD. Intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems The product is a medical device (chemistry reagent) and is intended for the quantitative determination of creatinine in human serum, plasma, and urine using the ARCHITECT c Systems. The kit is provided as a ready to use liquid material consisting in two components: Reagent 1 and Reagent 2. According to the catalogue number, the kit is composed of three vials of 48 ml for Reagent 1 and three vials of 18 ml for Reagent 2 in the configuration 8L24-31. The configuration 8L24-41 consists in ten vials of 90 ml for Reagent 1 and ten vials of 34 ml for Reagent 2

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SPA·August 9, 2017

    Alinity c Lithium Reagent Kit- intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 08P5320

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·October 2, 2019

    MULTIGENT Lithium-intended for the quantitation of lithium in serum or plasma using respectively the ARCHITECT c Systems and the Alinity c analyzer List Number: 8L25-30

    FDA Enforcement
    Class II ·Terminated·Sentinel CH SpA·October 2, 2019

    Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.

    FDA Enforcement
    Class III ·Terminated·Sentinel CH SpA·October 13, 2021

    REF 3987, SAFESCRAPER CURVE TWIST, CE 0123, STERILE EO. Used in oral surgery.

    FDA Enforcement
    Class II ·Terminated·Meta C.G.M. Spa·June 9, 2021

    REF 4049 MICROSS, CE0123, STERILE EO. Used in oral surgery.

    FDA Enforcement
    Class II ·Terminated·Meta C.G.M. Spa·June 9, 2021

    LMA Esophageal Intubation Detector (EID), Catalog Number EID100 The device is used to assist verification of placement of the endotracheal tube or esophageal/tracheal double lumen tube. This device is to be used as an adjunct to assess intubation. Its purpose is not to eliminate clinical judgment

    FDA Enforcement
    Class II ·Terminated·LMA North America Inc·July 25, 2012

    CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.

    FDA Enforcement
    Class II ·Terminated·LAP of America Laser Applications, LLC·June 11, 2014

    LAP LASER PICTOR 3D Multi Color Laser System PICTOR 3D is a LAP laser system which uses multi projection format that defines isocenters, field and MLC contours along with a 3D patient view.

    FDA Enforcement
    Class II ·Terminated·LAP of America Laser Applications, LLC·July 2, 2014