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

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    Detectaplast Nitril blue gloves,2 pcs in a zipper bag,size large

    Device
    EU MDR · Eu Md Class 1 ·Shandong Blue Sail Health Technology Co.,Ltd·On the market

    Short Percutaneous Antenna with Thermosphere" Technology Standard Percutaneous Antenna with Thermosphere" Technology; The product is packaged in a blister with a tyvek lid, contained in a display box. The numbers of units per carton is 1. Long Percutaneous Antenna with Thermosphere" Technology Product Usage: The Covidien Emprint Ablation System is intended for use in percutaneous,laparoscopic, and intraoperative coagulation (ablation) of soft tissue, including partial or complete ablation of non-resectable liver tumors. The CovidienEmprint Ablation System is not intended for use in cardiac procedures

    FDA Enforcement
    Class II ·Terminated·Covidien Medical Products (Shanghai) Manufacturing L.L.C.·March 23, 2016

    Digitial Medica X-ray Imagining System, Model: uDR 596i, RX, CE0123, UDI:(01) 06971576833023 - Product Usage: intended to used by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, limbs and trunk. Not for mammography.

    FDA Enforcement
    Class II ·Terminated·Shanghai United Imaging Healthcare Co., Ltd.·March 10, 2021

    GE Healthcare Carestation anesthesia system Power Management Board (PMB) Field Replaceable Unit (FRU), 2076139-001-S

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·December 24, 2025

    GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 750 A1, REF 1012-9750-000; Carestation 750 A2, REF 1012-9750-002; Carestation 750c A1, REF 1012-9755-000; Products for which affected PMB can be used as a spare part: Carestation 750c A2, REF 1012-9755-002

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·December 24, 2025

    GE Healthcare Carestation anesthesia system, product number and REF numbers: Carestation 610 A1, REF 1012-9620-222; Carestation 620 A1 REF 1012-9620-000; Carestation 620 A1, REF 1012-9620-200; Carestation 620 A1, REF 1012-9620-202; Carestation 620 SE A1, REF 1012-9620-212; Carestation 630 A1, REF 1012-9650-222; Carestation 650 A1, REF 1012-9650-000; Carestation 650 A1, REF 1012-9650-200; Carestation 650 A1, REF 1012-9650-202; Carestation 650 SE A1, REF 1012-9650-212; Carestation 650c A1, REF 1012-9655-202; Anesthesia Gas Machine Products for which affected PMB can be used as a spare part: Carestation 620 A2, REF 1012-9620-002 00840682124546 Carestation 620 SE A2, REF 1012-9620-012 00195278569677 Carestation 650 A2, REF 1012-9650-002 00840682124560 Carestation 650 SE A2, REF 1012-9650-012 00195278569684 Carestation 650c A1, REF 1012-9655-000 00840682103954 Carestation 650c A2, REF 1012-9655-002 00840682124539 Carestation 650c A1, REF 1012-9655-200 00195278439543

    FDA Enforcement
    Class I ·Ongoing·GE Medical Systems China Co., Ltd.·December 24, 2025

    The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.

    FDA Enforcement
    Class II ·Ongoing·GE Hangwei Medical Systems, Co. LTD·December 20, 2023

    The System is designed as a modular system with components that include an Overhead Tube Suspension with tube/collimator, wallstand, Table, X-ray generator, and cleared wireless digital detectors. The list of detectors verified and validated for use with the Discovery XR656 HD system, including their specifications, are provided in the user documentation. The System generates diagnostic The components may be combined in different configurations to meet specific customer needs. In addition, upgrade configurations are available for predicate devices. The optional image pasting function enables the operator to stitch sequentially acquired radiographs into a single image. This 510(k) is to incorporate the VolumeRad advanced application that was currently available on the Discovery XR656 product onto the Discovery XR656 HD, as well as introduce a new Metal Artifact Reduction Algorithm, and an optional standalone console to take any HelixTM acquired images via DICOM (such as from a Discovery XR656 HD, Optima XR646 HD, or Optima XR240amx) and process the images independently of the system it was acquired on.

    FDA Enforcement
    Class II ·Ongoing·GE Hangwei Medical Systems, Co. LTD·December 20, 2023

    ANA Control

    Device
    EU IVDR · Eu Ivd Class B ·SHENZHEN EVER-BLUE BIOTECH CO., LTD.·On the market·1 country

    ANA Control

    Device
    EU IVDD · Eu Ivd General ·SHENZHEN YHLO BIOTECH CO., LTD.·On the market

    ANA SCREENING

    Device
    EU IVDD · Eu Ivd General ·Hunan Wellgrow Biotech Co., Ltd.·On the market·32 countries

    LIA-ANA-Profile

    Device
    EU IVDD · Eu Ivd General ·SHENZHEN YHLO BIOTECH CO., LTD.·On the market

    LIA-ANA-Profile

    Device
    EU IVDD · Eu Ivd General ·SHENZHEN YHLO BIOTECH CO., LTD.·On the market

    LIA-ANA-Profile

    Device
    EU IVDD · Eu Ivd General ·SHENZHEN YHLO BIOTECH CO., LTD.·On the market

    LIA-ANA-Profile

    Device
    EU IVDD · Eu Ivd General ·SHENZHEN YHLO BIOTECH CO., LTD.·On the market

    LIA-ANA-Profile

    Device
    EU IVDD · Eu Ivd General ·SHENZHEN YHLO BIOTECH CO., LTD.·On the market

    LIA-ANA-Profile

    Device
    EU IVDD · Eu Ivd General ·SHENZHEN YHLO BIOTECH CO., LTD.·On the market

    LIA-ANA-Profile

    Device
    EU IVDD · Eu Ivd General ·SHENZHEN YHLO BIOTECH CO., LTD.·On the market

    LIA-ANA-Profile

    Device
    EU IVDD · Eu Ivd General ·SHENZHEN YHLO BIOTECH CO., LTD.·On the market

    LIA-ANA-Profile

    Device
    EU IVDD · Eu Ivd General ·SHENZHEN YHLO BIOTECH CO., LTD.·On the market