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

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    life+cel, Replacement battery for Cardiac Science FirstSave Survivalink; OEM P/N:9141-001, Part #: 2L561, Lithium Sulfur Dioxide, Voltage 12V, 7.5 amps., Mfg for Exocomm Technology Group; Mfg by Nordix, Inc.

    FDA Recall
    Terminated ·Exocomm Tech Grp·Product code MKJ·September 3, 2007

    Intelerad InteleShare software, with ProViewer component

    FDA Recall
    Open, Classified ·DICOM Grid, Inc.·Product code LLZ·November 18, 2025

    ARIES Flu A/B & RSV Assay , REF 50-10020, UDI # 00840487100158

    FDA Recall
    Open, Classified ·Luminex Corporation·Product code OZE·February 20, 2019

    Zebra Thermal Barcode Printer GX430t, Model no. YSW 1000 or YSW 2000, may have been sold as an optional accessory for Sensititre Aris HIQ system YV4000-VZ

    FDA Recall
    Open, Classified ·Remel, Inc·Product code LRG·February 12, 2025

    AQUAPAK 340 SW, 340 ML W/040B ADAPTOR, BRI Product Usage: The Humidifier Adaptor is an accessory which allows connection of sterile water or sterile saline to a humidifier circuit for the addition of water vapor to inhalation therapy gases. Only the 040 Humidifier adaptor packaged with the water bottle is affected by this recall.

    FDA Recall
    Terminated ·Teleflex Medical·Product code BTT·January 14, 2015

    The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis tool for diagnostic images by trained healthcare professionals, including radiologists, physicians, technologists, clinicians and nurses. It is also intended for use as a clinical review workstation throughout the healthcare facility. The workstation interface provides the user with a means to display, manipulate, archive, print and export images when connected with the Centricity PACS infrastructure.

    FDA Recall
    Terminated ·GE Healthcare It·Product code LLZ·June 11, 2013

    Ambra PACS, Ambra ProViewer. Software for use as a primary diagnostic and analysis tool for diagnostic images.

    FDA Recall
    Open, Classified ·DICOM Grid, Inc. d/b/a Ambra Health·Product code LLZ·June 23, 2022

    CDI Blood Parameter Monitoring System 500 including all Catalog Numbers to include: Catalog # 500AVHCT with Arterial and Venous blood parameter modules and Hematocrit/Saturation probe. Catalog Number 500AHCT, CDI 500 Monitor with Arterial blood parameter module and Hematocrit/Saturation probe. Catalog Number 500AV CDI 500 Monitor with Arterial and Venous blood parameter modules; and Catalog 500A, CDI 500 Monitor with Arterial blood parameter module. Intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and /or venous pH, PCO2, K+, or oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·September 23, 2011

    CDI Blood Parameter Monitoring System 500 Product Usage: The CDl Blood Parameter Monitoring System 500 is intended for use during cardiopulmonary bypass procedures when continuous monitoring of arterial and/or venous pH, PC02 , P02, K+, oxygen saturation, hematocrit, hemoglobin, and temperature are desired.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·December 6, 2011

    SHAPE ARM, DUAL SH2, an articulating, arm bracket that is attached to the service head of boom systems which are used for supporting and positioning equipment in operating rooms and patient care areas. The product comes as a component of kit part number 0682400254 and the Arm part number in the kit is P17084 . The kit, when assembled, supports a flat-panel video monitor that is attached to one of two types of Stryker Communications boom systems, EDS or FLEXiS.

    FDA Recall
    Terminated ·Stryker Communications·Product code BRY·March 17, 2014

    Terumo Cardiovascular Systems, CDI 100 Hematocrit/Oxygen saturation monitoring system, catalog 100.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·April 21, 2011

    Terumo Cardiovascular Systems, CDI blood parameter monitoring system 500 with arterial blood parameter module and hematocrit/saturation probe, catalog 500AHCT.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·April 21, 2011

    CDI Blood Parameter Monitoring System 500, 500AV. Intended for use during cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012

    CDI Blood Parameter Monitoring System 500, 500AHCT. Intended for use during cardiopulmonary bypass procedures.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·February 3, 2012

    CDI Blood Parameter Monitoring System 500 Cardiopulmonary bypass on-line blood gas monitor Product Usage: The CDL System 500 provides continuous, on-line monitoring of the extracorporeal partial pressure of oxygen and carbon dioxide, pH, potassium, oxygen saturation, hematocrit, hemoglobin and temperature. In addition, calculated values of base excess, bicarbonate, oxygen saturation, and oxygen consumption may also be provided. These parameters are displayed at either actual temperature or adjusted to 37 C. For documentation purposes, the system 500s integral printer provides a hard copy of displayed parameters.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DRY·March 14, 2016

    BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code BRY·June 24, 2024

    BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code BRY·June 24, 2024

    BD PYXIS MEDBANK TWR MN CR-8HH-3FM-P, REF: 169-99 containing software version 3.9.1.9

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code BRY·June 24, 2024

    BD Pyxis: MedStation ES (Main), REF: 323; MedStation ES Tower, REF: 352; Anesthesia Station ES, REF: 327; CII Safe ES, REF: 1116-00; CII Safe ES, Desktop PC, Wired Scanner, REF: 107-254-01; CII Safe ES, Desktop PC, Wireless Scanner, REF: 107-255-01; CII Safe ES, Desktop PC, Wired Scanner 1.7.3, REF: 107-256-01; CII Safe ES, Desktop PC, Wireless Scanner 1.7.3, REF: 107-257-01

    FDA Recall
    Open, Classified ·CareFusion 303, Inc.·Product code BRY·May 2, 2024

    Cardinal, Digital Bariatric Scale 1) model 6876, Cap 600 and 2) model 6868 Cap 1000

    FDA Recall
    Terminated ·Cardinal Scale Mfg Co·Product code FRI·December 23, 2015