BEUDAMED
    31 results · 14ms · Sources: EU EUDAMED, US FDA

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    Cardinal Health Alaris Pump Module (formerly Medley Pump Module), Model 8100, Cardinal Health, San Diego, CA. (All Alaris Pump modules shipped prior to December 23, 2007 are subject to this recall)

    FDA Recall
    Terminated ·Cardinal Health 303 Inc DBA Alaris Products·Product code FRN·October 29, 2007

    EpiFix Fixation Device for Epidural Catheters, REF 670M, Unomedical, Ltd., Great Britain.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code KMK·February 15, 2007

    StayFix Fixation Device for Percutaneous catheters, REF 680ME, (small) 5F - 14F, Merit Medical, Unomedical, Ltd., Great Britain.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code KMK·February 15, 2007

    StayFix Fixation Device for Percutaneous catheters, REF 685ME, (large) 12F - 22F, Merit Medical, Unomedical, Ltd., Great Britain.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc·Product code KMK·February 15, 2007

    ResMed S8 Continuous Positive Airway Pressure (CPAP) Flow generator with the following model names and product codes: S8 AUTOSET VANTAGE, #33112; S8 COMPACT, #33030; S8 ELITE, #33021; S8 ESCAPE, #33007.

    FDA Recall
    Terminated ·Resmed Corporation·Product code BZD·April 23, 2007

    ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.

    FDA Enforcement
    Class II ·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013

    BD AutoShield Pen Needle (Re order Number : 329300)

    FDA Recall
    Terminated ·Becton Dickinson & Company·Product code FMI·April 23, 2007

    OsteoStim Cervical Allograft (Lordotic Cervical Spacer) H. 7mm; W. 14mm; L. 10mm., Catalog Number: 45-5537 and Catalog Number : LGAL906, Distributed by EBI. (dba Biomet Spine, Biomet Trauma, Biomet Bracing, Biomet Osteobiologics) Parsippany, New Jersey 07054

    FDA Recall
    Terminated ·Product code MQV·October 23, 2007

    Inovel N95 HealthCare Particulate Respirator, Model/Catalog Number: FRN95-SEZ, Expiration Date: 07/13/2010.

    FDA Recall
    Terminated ·Inovel LLC·Product code MSH·July 23, 2008

    Biogel Skinsense Polyisoprene Surgical Gloves, Non-Latex, Sterile, (Size 8) Made in Malaysia

    FDA Recall
    Terminated ·Molnlycke Health Care, Inc·July 20, 2007

    Generation 4 electronic liquid gauges used on the Caire Liberator, Stroller, Sprint, and Hi-Flow Portable oxygen unit.

    FDA Recall
    Terminated ·Caire, Inc.·Product code BYJ·October 23, 2007

    HD11XE Diagnostic Ultrasound System

    FDA Recall
    Terminated ·Philips Medical Systems·Product code IYN·April 25, 2007

    Steris QFC1728 and QFC1729 Quick Connects used in connections and processing endoscopes. The QFC1728 is used to process the Fujinon 250/270/450/470/490 Group 5 and 530/590 series GI Endoscopes w/o Water Jet. The QFC1729 is used to process 250/450 Group 5 and 530/590 series Endoscopes w/ Water Jet.

    FDA Recall
    Terminated ·Steris Corp·Product code MED·February 23, 2007

    Gyrus CyberWand Ultrasonic Lithotripter System includes: CW-USLS CyberWand USL System CW-USLT CyberWand USL Transducer CW-USLRBP CyberWand USL Renal/Bladder Probe Set CW-USLTT CyberWand USL Transducer Sterilization Tray

    FDA Recall
    Terminated ·Gyrus ACMI Corporation·Product code FFK·May 23, 2007

    Cytomics FC 500 Flow Cytometry System with CXP Software, Part Numbers: 626553, Version 2.2

    FDA Recall
    Terminated ·Beckman Coulter Inc·Product code GKZ·August 1, 2007

    Synovis Peri-Strips Dry with Veritas Collagen Matrix Circular Staple Line Reinforcement, (PSD 28-U-V), 28mm, US Surgical Staplers. Each package contains the following components: Cartridge and anvil assemblies, Cartridge cone, PSD Gel, & C-clip

    FDA Recall
    Terminated ·Synovis Surgical Inovation Div. of·Product code FTM·March 16, 2007

    Biograph 40 TruePoint, Biograph PET/CT Scanner, Catalog No. 10097303, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc·Product code KPS·July 23, 2007

    Biograph 16, Biograph PET/CT Scanner, Catalog No. 872858, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc·Product code KPS·July 23, 2007

    Biograph DUO LSO, Biograph PET/CT Scanner, Catalog No. 8728813, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc·Product code KPS·July 23, 2007

    Biograph 40 - 3 Ring, Biograph PET/CT Scanner, Catalog No. 10097233, Manufactured by Siemens Medical Solutions USA, Inc., 810 Innovation Drive, Knoxville, TN 37932 USA, TEL: 865-218-2534

    FDA Recall
    Terminated ·Siemens Medical Solutions USA Inc·Product code KPS·July 23, 2007