BEUDAMED
    19 results · 12ms · 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: Terminated ×

    740 Series Multiparameter Monitor Software Version 3.0 Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740-3NN, and 740M-3NN CAS Medical Systems, Inc., Branford, Connecticut 06405 Indicated for use for non-invasive monitoring of blood pressure, oxygen saturation, pulse and temperature of adults, pediatric and neonatal patients, in the care of health professionals.

    FDA Recall
    Terminated ·CAS Medical Systems, Inc.·Product code MHX·June 24, 2008

    HERBERT MINI BONE SCREW 2 and HERBERT/WHIPPLE C ANN BONE. Items starting with 0011500 and 0011520.

    FDA Enforcement
    Class II ·Terminated·Zimmer, Inc.·February 26, 2014

    Medtronic O-arm Imaging System Mobile X-ray system. Model No. BI-700-00027 and BI-700-00028 The 0-arm Imaging System is a mobile x-ray system designed for 2D fluoroscopic and 3D imaging and is intended to be used where a physician benefits from 2D and 3D information of anatomic structures and objects with high x-ray attenuation such as bony anatomy and metallic objects. The 0-ann Imaging System is compatible with certain Image Guided Surgery Systems.

    FDA Enforcement
    Class II ·Terminated·Medtronic Navigation, Inc.·March 12, 2014

    Herga foot switch, model 6289-WS, a component of the ROSA Robotized Stereotactic Assistant Surgical Device, Model 2.5.8. The firm name on the foot switch label is Herga Electric Limited, Bury, St. Edmunds, Suffolk IP32 6NN. ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software and uses fiducial markers or optical registration. The system is intended for use by neurosurgeons to guide standard neurosurgical instruments. It is indicated for any neurosurgical condition in which the use of stereotactic surgery may be appropriate

    FDA Enforcement
    Class II ·Terminated·Zimmer Biomet, Inc.·September 20, 2017

    EMD Chemicals, Harleco Brand Ethanol Standard, 1.0 mg/ml; 1.0 mg Ethanol in 1 ml, 10 ampules; Item number 68991/95; in vitro diagnostic.

    FDA Recall
    Terminated ·EMD Chemicals Inc·Product code DNN·March 27, 2008

    EndoTool Drug Dose Calculator-Software Version 7.2.1800.3 and 7.2.1825.5

    FDA Recall
    Terminated ·Hospira, Inc.·Product code DNN·July 26, 2010

    Umbilical Vessel Catheter Kit, Catalog number 900-1408. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.

    FDA Recall
    Terminated ·Customed, Inc Calle Igualdad Final # 7·Product code GBN·October 8, 2014

    Accuprobe Group B Streptococcus Culture Identification Test, Catalog Number 2820B, Batch Number 531379, Gen-Probe, Incorporated, San Diego, CA. 92121

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code MDK·May 2, 2007

    Mycobacterium Tuberculosis Complex Culture Identification Test, 2860.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code LQF·December 30, 2008

    Gen-Probe AccuProbe Group B Streptococcus Culture Identification Test Kit, 2820.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code MDK·December 30, 2008

    Mycobacterium Avium Complex Culture Identification Test Identification Test Kit, 2835.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code LQF·December 30, 2008

    Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test, Catalog number 1001,

    FDA Recall
    Terminated ·Gen Probe Inc·Product code NDZ·June 11, 2004

    APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.

    FDA Recall
    Terminated ·Gen-Probe Inc·Product code OIE·April 17, 2014

    APTIMA Urine Collection Kit; Catalog Number 301040, Lots 27231, 27232, 27233, and 27234. Product Usage: The APTIMA Urine Specimen Collection Kit for Male and Female Urine Specimens is for use with APTIMA assays. The APTIMA Urine Specimen Collection Kit is intended to be used for the collection and transport of male or female urine specimens.

    FDA Enforcement
    Class III ·Terminated·Gen-Probe Inc·June 25, 2014

    The ICS CHARTR EP 200

    FDA Enforcement
    Class II ·Terminated·GN Otometrics·October 30, 2019

    Dario Blood Glucose Monitoring System, Model No. 1015-05, running Android software versions 4.3.0-4.3.2

    FDA Recall
    Terminated ·LABSTYLE INNOVATIONS 7, Derekh Menakhem Begin Ramat Gan Israel·Product code NBW·August 29, 2019

    Behind-the-Ear hearing aids, Model Numbers: Q962-DRW, T561-DRW, T562-DRW, T762-DRW, T777-DW, AMZ964-DRW, ET588-DWH, ET598-DW, ET788-DWH, ET798-DW, ET988-DWH, ET998-DW, FT861-DRW, FT862-DRW, RE561-DRWC, RE762-DRW, RE961-DRWC, RE962-DRW, PZ862-DRW, LT561-DRW, LT561-DRWZ, LT562-DRW, LT588-DW, LT761-DRW, LT761-DRWZ, LT762-DRW, LT777-DW, LT788-DW, LT961-DRW, LT961-DRWZ, LT962-DRW, LT967-DW, LT977-DW, LT988-DW, TST1763-DRW, TST1764-DRW, TST663-DRW, TST963-DRW, TST964-DRW, VA861-DRW, VA861-DRWZ, VA862-DRW

    FDA Enforcement
    Class II ·Terminated·GN Hearing A/S·December 4, 2019

    In-the-Ear hearing aids, Model Numbers: T9ITC-DW-LP, FT6ITC-D-MP, FT6ITE-D-MP, FT8CIC-MP, FT8ITC-W-HP, FT8ITC-W-LP, FT8ITC-W-MP, FT8ITE-DW-HP, FT8MIH-W-HP, FT8MIH-W-MP, LT5CIC-MP, LT5CIC-UP, LT5IIC-LP, LT5ITC-DW-MP, LT5ITC-DW-UP, LT5ITE-DW-HP, LT5ITE-DW-MP, LT5ITE-DW-UP, LT5MIH-W-HP, LT5MIH-W-MP, LT5MIH-W-UP, LT7CIC-HP, LT7CIC-LP, LT7CIC-MP, LT7CIC-W-MP, LT7IIC-LP, LT7ITC-DW-LP, LT7ITC-DW-MP, LT7ITC-MP, LT7ITC-W-HP, LT7ITC-W-MP, LT7ITE-DW-HP, LT7ITE-DW-MP, LT7ITE-DW-UP, LT7ITE-W-UP, LT7MIH-W-HP, LT7MIH-W-LP, LT7MIH-W-MP, LT9CIC-HP, LT9CIC-MP, LT9CIC-W-MP, LT9IIC-LP, LT9ITC-DW-HP, LT9ITC-DW-LP, LT9ITC-DW-MP, LT9ITE-DW-HP, LT9ITE-DW-MP, LT9ITE-DW-UP, LT9MIH-HP, LT9MIH-MP, LT9MIH-W-HP, LT9MIH-W-LP, LT9MIH-W-MP, TST17IIC-LP, TST17ITC-DW-HP, TST17ITE-HP, TST17MIH-W-UP, TST6CIC-HP, TST6IIC-LP, TST6ITC-MP, TST6ITC-W-HP, TST6ITC-W-MP, TST6ITE-DW-UP, TST6ITE-HP, TST6ITE-W-UP, TST6MIH-W-HP, TST9ITC-DW-MP, TST9ITE-DW-HP, TST9ITE-MP, TST9MIH-W-MP, VA8CIC-HP, VA8CIC-MP, VA8IIC-LP, VA8ITC-DW-HP, VA8ITC-DW-MP, VA8ITC-W-MP, VA8ITE-D-HP, VA8ITE-DW-HP, VA8ITE-DW-UP, VA8MIH-W-MP

    FDA Enforcement
    Class II ·Terminated·GN Hearing A/S·December 4, 2019

    Crosseal, fibrin sealant (human), This package***, One Applicator, Two Vial cups, Sterile, Disposable, Single Use, For Usage***, Rx Only, Distributed by American Red Cross Blood Services, Washington, DC 20006, Manufactured by: Medimop Medical Projects Ltd, for OMRIX biopharmaceuticals, Utd, MDA blood bank, Sheba Hospital, Romat-Gan, PO8 888, Kiryat Ono 55000 Israel

    FDA Recall
    Terminated ·Omrix Biopharmaceuticals, Ltd. Plasma Fract. Inst. Magen David Adom Blood Services Ctr., Sheba Hospital Ramat Gan Israel·Product code FMF·August 6, 2004