BEUDAMED
    31 results · 19ms · Sources: EU EUDAMED, US FDA

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    BARRE DE LIT COULEUR RAL 5002 NUE

    Device
    EU MDR · Eu Md Class 1 ·ALTER ECO SANTE Sarl·On the market

    BARRE DE LIT COULEUR RAL 4006 NUE

    Device
    EU MDR · Eu Md Class 1 ·ALTER ECO SANTE Sarl·On the market

    MANC-OUT-NI

    Basic UDI-DI
    EU MDR · Eu Md Class 1 ·ACIME FRAME·1 device

    Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000

    FDA Enforcement
    Class II ·Ongoing·Medicrea International·January 21, 2026

    Blue Ortho TKA Pro v2.1 software installed on the Exactech GPS system -indicated for stereotaxic surgery in Knee Arthroplasty Catalog Reference: L00002

    FDA Enforcement
    Class II ·Terminated·Blue Ortho·February 19, 2020

    Punch Hair Matic A surgical hair transplant device designed for automation of follicular transplantation.

    FDA Enforcement
    Class II ·Terminated·MEDICAMAT S.A.·March 12, 2014

    Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174

    FDA Enforcement
    Class II ·Ongoing·Medicrea International·January 21, 2026

    Etest¿ PIP/TAZO/CON-4 PTC 256 -pack of 30 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.

    FDA Enforcement
    Class I ·Terminated·Biomerieux·December 30, 2015

    Etest¿ Piperacillin/tazobactam (4 ug/mL) PTc0.016-256-pack of 30 tests WW Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.

    FDA Enforcement
    Class I ·Terminated·Biomerieux·December 30, 2015

    Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests US. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.

    FDA Enforcement
    Class I ·Terminated·Biomerieux·December 30, 2015

    Etest¿ PIP/TAZO/CON-4 PTC 256 - Foam of 100 tests WW. Etest¿ is a quantitative technique for determining the antimicrobial susceptibility of Gram-negative and Gram-positive aerobic bacteria.

    FDA Enforcement
    Class I ·Terminated·Biomerieux·December 30, 2015

    Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use during cardiovascular to create and maintain, monitor pressure in the balloon catheter - balloon inflation device for angioplasty procedures

    FDA Enforcement
    Class II ·Terminated·PEROUSE MEDICAL·January 7, 2015

    Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyphoplasty or other interventional kyphoplasty or other interventional procedures, to create and monitor pressure In the balloon catheter and pressure In the balloon catheter and to to deflate the balloon catheter

    FDA Enforcement
    Class II ·Terminated·PEROUSE MEDICAL·January 7, 2015

    Eon 100 system included the following product reference numbers and names: Reference no. 77345- Glucose (GPSL) Reference no. 77450- Uric acid (AUVD) Reference no. 77435- Triglycerides (TGML) Reference no. 77295- Cholesterol (CHVD) Reference no. 77301- Cholesterol HDL (HDLL) Reference no. 77310- Cholesterol, LDL (LDLL)

    FDA Enforcement
    Class II ·Terminated·ELITech Clinical Systems SAS·November 11, 2015

    Eon 300 system includes the following product reference numbers and names: Reference no. 79345 Glucose (GPSL) Reference no. 79450 Uric acid (AUVD) Reference no. 79435 Triglycerides (TGML) Reference no. 79295 Cholesterol (CHVD) Reference no. 79301 Cholesterol HDL (HDLL) Reference no. 79310 Cholesterol, LDL (LDLL)

    FDA Enforcement
    Class II ·Terminated·ELITech Clinical Systems SAS·November 11, 2015

    Envoy 500 system includes the following product reference numbers and names: 55345 ENVOY 500 Glucose 55450 ENVOY 500 URIC ACID REAGENT KIT 55435 ENVOY 500 TRIGLYCERIDES REAGENT KIT, 55297 ENVOY 500 CHOLESTEROL REAGENT KIT, 55335 ENVOY 500 CREATININE REAGENT KIT 55301 ENVOY 500 HDL CHOLESTEROL REAGENT 55310 ENVOY 500 LDL CHOLESTEROL REAGENT KIT

    FDA Enforcement
    Class II ·Terminated·ELITech Clinical Systems SAS·November 11, 2015

    NucliSENS Lysis Buffer Extended lot for RES 76675

    FDA Enforcement
    Class II ·Terminated·BioMerieux SA·November 15, 2017

    VIDAS NT-pro-BNP Product Usage: VIDAS¿ NTproBNP (PBNP) is an automated quantitative test for use on the instruments of the VIDAS family for the determination of N terminal fragment of Btype natriuretic peptide in human serum or plasma (lithium heparin) using the ELFA technique (EnzymeLinked Fluorescent Assay). The VIDAS NTproBNP (PBNP) test is used as an aid in the diagnosis of suspected congestive heart failure.

    FDA Enforcement
    Class III ·Terminated·Biomerieux France Chemin De L'Or·September 21, 2016

    ELITech Clinical Systems reagents used on the Selectra ProS and ProM systems that utilize the Trinder Reaction method. The following product reference numbers and names: GPSL-025O: Glucose PAP SL AUML-0250: URIC ACID MONO SL CHSL-0250: CHOLESTEROL SL, TGML-0250: TRIGLYCERIDES SL, CRSL-0250: CREATININE PAP SL HDLL-0230: CHOLESTEROL HDL SL 2G LDLL-0230: CHOLESTEROL LDL SL 2G

    FDA Enforcement
    Class II ·Terminated·ELITech Clinical Systems SAS·November 11, 2015

    Remisol Advance Software (Driver Architect) Catalog Number B32129 The Remisol Advance Data Manager (Stand alone Data Management Systems) collects and manages data and manages workflows for connected systems. (i.e. Beckman Coulter Instruments, Automations, LIS &). It provides data analysis capabilities such as automatic results validation, delta checking, reflex testing, quality control, results editing and data management (i.e. archiving and restoration of patient results). The Remisol Advance system also offers workstation consolidation to three Beckman Coulter instruments from a single user console.

    FDA Enforcement
    Class II ·Terminated·Normand Informatique·December 20, 2017