BEUDAMED
    29 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 FDA Recall ×

    Cardiomedics CardiAssist External Counterpulsation System, circulatory assist device, Series 4000.

    FDA Recall
    Terminated ·Product code DRN·April 9, 2009

    Medline Convenience Kits: 1) TRUNK KIT W/EXPIRATION, Model Number: DYKM1361A; 2) TRUNK KIT 1EA, Model Number: DYKM2013; 3) TRUNK KIT 1EA, Model Number: DYKM2013A; 4) RN TRUNK KIT, Model Number: DYKM2699; 5) TRUNK KIT, Model Number: DYKTRUNK1

    FDA Recall
    Open, Classified ·Product code LRO·January 5, 2026

    Replacement leadwires with grabber ends: REF/Catalog Number Description 2106388-005 Replacement ECG Leadwire, grabber, BRN V, AHA, 74 cm/ 29 in 2106388-101 Replacement ECG Leadwire, grabber, LL , AHA, 130 cm/ 51 in 2106388-103 Replacement ECG Leadwire, grabber, GRN RL, AHA, 130 cm/ 2106388-107 Replacement ECG Leadwire, grabber, BLK N, IEC, 130 cm/ 51 in 2106392-004 Replacement ECG Leadwire, grabber, ORG V, AHA, 74 cm/ 29 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter.

    FDA Recall
    Terminated ·GE Healthcare, LLC·Product code DSA·May 10, 2019

    CHROMagar VRE Base; 5000 ml (67.3 g/L) IVD; For InVitro Diagnostic Use; CHROMagar is a trademark of Dr. A Rambach; CHROMagar, Paris, France Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.

    FDA Recall
    Terminated ·DRG International Inc·Product code JSO·November 9, 2009

    DRG:HYBRiD-XL Insulin. Model/Catalog Number: HYE-5361

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code CFP·October 7, 2024

    CHROMagar 0157; 5000 ml (29.2 g/L) EE222; IVD For In Vitro Diagnostic Use, CHROMagar is a trademark of Dr. A. Rambach; CHROMagar, Paris France. Medium for the detection of Van A Van B VRE. The majority of customers use this product for food, environmental, research or veterinarian use.

    FDA Recall
    Terminated ·DRG International Inc·Product code JSO·November 9, 2009

    17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma Model/Catalog Number: EIA-1292

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code JLX·September 13, 2024

    C-Peptide ELISA : IVD measurement of C-Peptide in serum, plasma (EDTA-, heparin- or citrate plasma) and urine. Catalog # EIA-1293

    FDA Recall
    Terminated ·DRG International, Inc.·Product code JKD·December 21, 2021

    Total Thyroxine (T4) ELISA; REF EIA-1781

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code KLI·October 18, 2021

    Product Name: Salivary Testosterone ELISA Model/Catalog Number: SLV-3013 Product Description: An enzyme immunoassay for the quantitative in vitro diagnostic measurement of free active testosterone in saliva.

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code CDZ·July 5, 2024

    Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISA

    FDA Recall
    Open, Classified ·DRG International, Inc.·Product code CDX·June 4, 2025

    Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Model Number: R1053618 and R1076709. These are retrofitted device.

    FDA Recall
    Open, Classified ·DRE Medical Group Inc·Product code MNT·May 15, 2023

    PolyTiter software version 2.8 for use in the Polymedco PolyTiter Immunofluorescent Titration System, DiaSorin part # PT100 which is programmed for DiaSorin ANAFLUOR Indirect fluroescent Antibody Test For the detection and titration of circulating antinuclear antibodies. REF: 1624, 1662, 1660, 6624, 1604

    FDA Recall
    Terminated ·Diasorin Inc.·Product code DHN·June 30, 2004

    C-Reactive Protein Kit for use on the SPAplus, REF NK044.S.A, Rx only, UDI (01)05051700018456,

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DCN·April 25, 2019

    Tina-quant C-Reactive Protein Gen.3, Catalog number 05172373190 - Product Usage: the in vitro quantitative determination of CRP in human serum and plasma on Roche automated clinical chemistry analyzers.

    FDA Recall
    Terminated ·Roche Diagnostics Operations, Inc.·Product code DCN·November 6, 2020

    ANA Fluorescent Test System and ANA Colorzyme Test System, Sub assembly catalog number SA 2013, Kit Catalog Numbers, 2000, 2002, 2003, 2004, 2005, 2100, 2200, 4000, 4200, 8024.1, and 8060, manufactured by Immuno Concepts N.A. Ltd, Sacramento, CA. The device is used in the screening and titration of circulating antinuclear antibodies by means of an immunofluoresence test. Products are to be used as an aid in the detection of antibodies associated with systemic rheumatic disease.

    FDA Recall
    Terminated ·Immuno Concepts Inc·Product code DHN·December 4, 2008

    Optilite C-Reactive Protein Kit - Product Usage: The Optilite C-Reactive Protein Reagent is intended for the quantitative in vitro determination of C-reactive protein (CRP) concentration in serum using the Binding Site Optilite analyser. Measurement of C-Reactive Protein aids in evaluation of the amount of injury to body tissues and for evaluation of infection, tissue injury, and inflammatory disorders. This test should be used in conjunction with other laboratory and clinical findings. The Optilite C-Reactive Protein Calibrator is intended for the calibration of the Optilite C-Reactive Protein Reagent on the Optilite analyser. The Optilite C-Reactive Protein Controls are intended for use in quality control by monitoring accuracy and precision for the Optilite C-Reactive Protein Reagent.

    FDA Recall
    Terminated ·The Binding Site Group, Ltd.·Product code DCN·February 19, 2019

    Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.

    FDA Recall
    Open, Classified ·Siemens Healthcare Diagnostics, Inc.·Product code DCN·March 11, 2025

    Inova Diagnostic Inc., NOVA Lite ANA KSL Kit Part Number: 708390. in vitro diagnostic.

    FDA Recall
    Terminated ·Inova Diagnostics Incorporated·Product code DHN·September 26, 2011

    Anti-dsDNA [125I] Radiobinding Assay Kit. For In-Vitro Diagnostic Use Catalog Number: NEA 103

    FDA Recall
    Terminated ·Perkinelmer Life Sciences, Inc.·Product code DHN·July 21, 2003