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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Status: Open, Classified ×

    Flow sensors kept as stand-alone user replaceable spare parts for the GEHC anethesia machines: 2089610-001 FLOW SENSOR, LEGACY VAR ORF BCG (blue, cleanable) 2089610-001-S FLOW SENSOR, LEGACY VAR ORF BCG, SERVICE (blue, cleanable) 2087640-001 FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG (gray, autoclavable) 2087640-001-S FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG, SERVICE (gray, autoclavable) 2096513-001-S FLOW SENSOR ASSEMBLY 5697309 R-FMI34109-FLOW SENSOR, LEGACY VAR ORF BCG 5697310 R-FMI34109-FLOW SENSOR, LEGACY VAR ORF AUTOCLAVABLE BCG

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code BSZ·August 2, 2021

    Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4599P-1

    FDA Recall
    Open, Classified ·Smiths Medical ASD Inc.·Product code JKA·September 6, 2023

    ABG II Modular Hip Stem Stryker Howmedica Osteonics Corp. Mahwah, NJ 07430 Stryker Ireland Carrigtwohill Industrial Estate, Carrigtwohill County Cork, Ireland. The ABG II Modular range of implants is constituted of 8 right stems and 8 left stems. The necks are made of GADS Vitallium, a proprietary Co Cr alloy that Stryker has developed. GADS stands for Gas Atomized Dispersion Strengthened. IT is a Co Cr alloy that is a corrosion resistant and demonstrates qualities of improved fatigue strength (with respect to regular Co Cr alloy). Neck Range - The ABG II modular neck range is composed of 10 reversible neck implants. There are different options in terms of length, version and neck angle. The AG II Modular necks come in two different lengths: 28 mm (short) and 36 mm (long). The necks are offered in two version angles ; 0 and 7. The 0 and 7 necks are available in 125, 130 and 135 neck angles.

    FDA Recall
    Open, Classified ·Stryker Howmedica Osteonics Corp.·Product code MEH·April 30, 2012

    a. Comply INDICATOR, COMPLY VAPOR GAS (250/BG 4BG/CS) 3M Model Number: 1248. b. 3M Attest INDICATOR, CHEMICAL VAPORIZEDHYDROGEN PEROXIDE (250/BG) Model Number: 1348.

    FDA Recall
    Open, Classified ·Mckesson Medical-Surgical Inc. Corporate Office 9954 Maryland Drive Deep Run Iii Ste. 4000 Richmond VA 23233·Product code JOJ·May 25, 2022

    Ambu VivaSight 2 DLT Endobronchial tube, 35 FR (Catalog Number 412351000), 37 Fr (Catalog Number 412371000), 39 Fr (Catalog Number 412391000), 41 Fr (Catalog Number 412411000)

    FDA Recall
    Open, Classified ·Ambu Inc.·Product code CBI·September 16, 2024

    HUDSON RCI mBrace, ET Tube Holder with Bite Block and 2 Point Head Strap, REF DYNJMBRC2B; tracheal tube fixation device

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code CBH·November 18, 2024

    HUDSON RCI mBrace, ET Tube Holder and 2 Point Head Strap, REF DYNJMBRC2; tracheal tube fixation device

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code CBH·November 18, 2024

    HUDSON RCI mBrace, ET Tube Holder with 4 Point Head Strap, REF DYNJMBRC4; tracheal tube fixation device

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code CBH·November 18, 2024

    Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000, 412391000, 412411000

    FDA Recall
    Open, Classified ·Ambu Inc.·Product code CBI·June 3, 2022

    AnchorFast Guard Select, Oral Endotracheal Tube Fastener, REF 9700,

    FDA Recall
    Open, Classified ·Hollister Incorporated·Product code CBH·December 23, 2024

    AnchorFast, Oral Endotracheal Tube Fastener, REF 9799,

    FDA Recall
    Open, Classified ·Hollister Incorporated·Product code CBH·December 23, 2024

    AnchorFast SlimFit, Oral Endotracheal Tube Fastener, REF 9787,

    FDA Recall
    Open, Classified ·Hollister Incorporated·Product code CBH·December 23, 2024

    HUDSON RCI mBrace, ET Tube Holder with Bite Block and 4 Point Head Strap, REF DYNJMBRC4B; tracheal tube fixation device

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code CBH·November 18, 2024

    AnchorFast Guard, Oral Endotracheal Tube Fastener, REF 9800,

    FDA Recall
    Open, Classified ·Hollister Incorporated·Product code CBH·December 23, 2024

    The VITROS XT Chemistry Products ALB-TP Slides is a single device that contains both an albumin test and a total protein test side by side separated by a plastic barrier sealed within a single slide frame. In this format, individual reactions occur, and test results are generated for each analyte independently of the other analyte. The ALB test is a multilayered, analytical element coated on a polyester support. For the albumin measurement, a drop of patient sample is deposited on the slide and is evenly distributed by the spreading layer to the underlying layers. When the fluid penetrates the reagent layer, the bromocresol green (BCG) dye diffuses to the spreading layer and binds to albumin in the sample. This binding results in a shift in wavelength of the reflectance maximum of the free dye. The color complex that forms is measured by reflectance spectrophotometry. The amount of albumin-bound dye is proportional to the concentration of albumin in the sample. Model/Catalog Number: 6844293

    FDA Recall
    Open, Classified ·Ortho-Clinical Diagnostics, Inc.·Product code CIX·July 10, 2024