BEUDAMED
    96 results · 6ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    Medline HOI LUMBAR REF DYNJ902823G Lot 20AKA895 Expiration 2021-05-31 1 each GTIN (01)10193489219180

    FDA Enforcement
    Class II ·Terminated·Medline Industries Inc·March 4, 2020

    N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic reagents for the quantitative determination of total homocysteine (HCY) in human serum, heparinized plasma and EDTA plasma by means of particle-enhanced immunonephelometry with BN II and BN ProSpec System. The device can assist in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·March 1, 2017

    VITROS Chemistry Products-HCY Reagent packaged in a kit carton. Catalog# 6802002. Used to quantitatively measure total homocysteine (HCY) concentration in human serum and plasma.

    FDA Enforcement
    Class II ·Terminated·Ortho-Clinical Diagnostics·June 26, 2013

    ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·June 4, 2025

    ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillary Pack Catalog number 03302138 (124581), SMN 10378677. Used on the ADVIA Centaur, ADVIA Centaur XP and ADVIA Centaur CP platforms. For in vitro diagnostic use in the quantitative determination of total homocysteine (HCY) in serum or plasma.

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc·July 9, 2014

    ST AIA-PACK Homocysteine (HCY) is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDT A plasma on TOSOH AIA System Analyzers. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria.

    FDA Enforcement
    Class II ·Terminated·Tosoh Bioscience Inc·January 2, 2019

    NEO SCREW 02.7-14MM LOCKING, REF W27 ST114, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius

    FDA Enforcement
    Class II ·Terminated·In2Bones, SAS·January 18, 2017

    SCREW 02.7-12MM LOCKING, REF W27 ST112: a) DRP, b) NEO, In2Bones, 28 chemin du petit bois, 69130 Ecully - France The NEOVIEW¿ Plating System is intended for fixation of intra-articular and extraarticular fractures of the distal radius and reconstruction of the distal radius

    FDA Enforcement
    Class II ·Terminated·In2Bones, SAS·January 18, 2017

    Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498

    FDA Enforcement
    Class II ·Ongoing·Siemens Healthcare Diagnostics, Inc.·June 4, 2025

    regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·September 25, 2024

    Regard Kit containing the Microtek decanter

    FDA Enforcement
    Class II ·Ongoing·ROi CPS LLC·August 28, 2024

    Regard Dressing Change Tray

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·May 19, 2021

    Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·March 9, 2022

    regard GS0098C - RESUSABLE RT BRONCH, Item Number: 830086003

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·June 15, 2022

    Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an infant heel warmer.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·August 11, 2021

    Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an infant heel warmer.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·August 11, 2021

    Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an infant heel warmer.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·August 11, 2021

    regard Item Number: 800774001, CV00979A - CV Minor Kit, Sterile.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·July 6, 2022

    Custom procedure packs, containing Clearlink Continu-Flo, labeled as follows: a) regard LD00200L-VAG DELIVERY MOTHER - JOPLIN, Item Number 830015012 b) regard GS00310C - Max Barrier Central Line Trpl Lumen 16cm, Sulfa-coated catheter, Item Number: 830027 c) regard GS00309B - Max Barrier Central Line Dual Lumen 16cm, Sulfa-coated catheter, Item Number: 830026 d) regard GS00307B - Max Barrier Central Line Trpl Lumen 20cm, Sulfa-coated catheter, Item Number: 830024 e) regard AN00211K - PICC PACK - WASHINGTON, Item Number, 880189011 f) regard GS00311B - Max Barrier Central Line Quad Lumen 20cm, Sulfa-coated catheter, Item Number: 830028 g) regard LD00866B-VAG DELIVERY MOTHER - LEBANON, Item Number 830084 h) regard LD00199NL-C SECTION MOTHER - JOPLIN, Item Number 830014 i) regard GS0348D - CVC TRIPLE LUMEN 20CM NON SULFA - , Item Number 830034 Product Usage: These custom procedural trays contain surgical instruments and accessories intended for use during a surgical procedure.

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·February 5, 2020

    Respirator Crash Cart Kit

    FDA Enforcement
    Class II ·Terminated·ROi CPS LLC·July 8, 2020