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

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    CareLink SmartSync Device Manager (24970A). used to interrogate cardiac implantable electronic devices (CIED).

    FDA Recall
    Open, Classified ·Medtronic Inc., Cardiac Rhythm and Heart Failure (CRHF)·Product code OSR·April 6, 2021

    Autosampler, Models: SIL-20ACXR CL, SIL-20ACHT CL, SIL-30AC CL

    FDA Recall
    Open, Classified ·Product code KIE·October 9, 2024

    Atrium Pneumostat Chest Drain Valve, Part Number 16100

    FDA Recall
    Open, Classified ·Atrium Medical Corporation·Product code KDQ·August 26, 2021

    Torrent Suite Dx Software versions 5.14 and earlier used in connection with Ion PGM DX Systems-IVD intended for targeted sequencing of human genomic DNA (gDNA) from peripheral whole-blood samples and DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) samples. The Ion PGM Dx Instrument System is not intended for whole genome or de novo sequencing Product Name Installer /SKU /Updater SKU: (1) Torrent Suite Dx Software 5.14 -A52422/ A52417 (2) Torrent Suite Dx Software 5.12.5- A46166/ A46167 (3)Torrent Suite Dx Software 5.8- A36601/ A36602 (4)Torrent Suite Dx Software 5.6.4- A33178/ A33178 (5)Torrent Suite Dx Software 5.0- A29166/ A29166

    FDA Recall
    Open, Classified ·Life Technologies Corporation·Product code PFF·February 7, 2024

    MI Cancer Seek REF MSC000 UDI Code: (01)00860008613325(21)H5HJHDSXF MI Cancer Seek is a single-site assay intended to provide tumor mutational profiling to be used by qualified healthcare professionals in accordance with professional oncology guidelines for cancer patients with previously diagnosed solid malignant neoplasms.

    FDA Recall
    Open, Classified ·CARIS LIFE SCIENCES·Product code PQP·June 17, 2025

    Artelon FlexBand Plus Ref: 41054 & 41057

    FDA Recall
    Open, Classified ·International Life Sciences·Product code OWW·February 6, 2026

    Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1)

    FDA Recall
    Open, Classified ·International Life Sciences·Product code OWW·February 6, 2026

    Artelon FlexBand Dynamic Matrix Ref: 31057

    FDA Recall
    Open, Classified ·International Life Sciences·Product code OWW·February 6, 2026

    VOCSN Multi-Function Ventilators: VOCSN+Pro (V+O+C+S+N+Pro, English), REF: PRT-00490-001; V+Pro (V+Pro, English), REF: PRT-01185-000, PRT-01185-002

    FDA Recall
    Open, Classified ·Ventec Life Systems, Inc.·Product code CBK·February 3, 2025

    Ventec Life Systems VOCSN Multi-Function Ventilator Model/Version/Catalog Number: V+O+C+S+N+Pro/English/PRT-00490-001; V+O+C+S+N+Pro/Japan/PRT-00490-100; V+C+Pro/English/PRT-00900-001; V+C+Pro/Japan/PRT-00900-100; V+C/English/PRT-01098-000; V+O+C+S+N/English/PRT-01100-000; V+O+C+S+N/English/PRT-01100-001;

    FDA Recall
    Open, Classified ·Ventec Life Systems, Inc.·Product code CBK·May 10, 2021

    VOCSN V+Pro package, REF: PRT-01198-000; VOCSN V+Pro unit, REF: PRT-01185-000

    FDA Recall
    Open, Classified ·Ventec Life Systems, Inc.·Product code NOU·March 25, 2026

    VOCSN Patient Breathing Package (Pediatric, Active, Oxygen, Blue) REF PRT-01013-000 with pouch REF PRT-00802-001). Used with the VOCSN Unified Respiratory System which provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation.

    FDA Recall
    Open, Classified ·Ventec Life Systems, Inc.·Product code CBK·January 9, 2024

    VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001

    FDA Recall
    Open, Classified ·Ventec Life Systems, Inc.·Product code CBK·May 8, 2026

    Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) (0.9% Sodium Chloride Irrigation, USP), Part Number REF BTLE-1250

    FDA Recall
    Open, Classified ·Bridge to Life Ltd·Product code KDN·June 12, 2025

    On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

    FDA Recall
    Open, Classified ·On-X Life Technologies, Inc.·Product code LWQ·February 1, 2026

    DELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: A007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG) in serum.

    FDA Recall
    Open, Classified ·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JHJ·January 10, 2019

    AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-112 - Product Usage: Quantitative determination of human gonadotrophin (hCG).

    FDA Recall
    Open, Classified ·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JHJ·January 10, 2019

    AutoDELFIA hCG Kit, In Vitro Diagnostic for the determination of human gonadotropin (hCG) Product Code: B007-101 - Product Usage: Quantitative determination of human gonadotrophin (hCG).

    FDA Recall
    Open, Classified ·PerkinElmer Life and Analytical Sciences, Wallac, OY Mustionkatu 6·Product code JHJ·January 10, 2019