BEUDAMED
    49 results · 21ms · Sources: EU EUDAMED, US FDA

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    BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect.

    FDA Recall
    Terminated ·Breg Inc·Product code ILO·January 14, 2013

    Custom Breast Biopsy Tray w/Sodium Chloride, Catalog # B9-15263A, packaged in bags, 1 tray/bag, 20 bags/case. Product Usage: A sterile medical device containing multiple components utilized by physician to perform a breast biopsy.

    FDA Enforcement
    Class II ·Terminated·Custom Healthcare Systems, Inc.·February 13, 2013

    BREG Sterile Polar Pads; 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 02510, 09901, 02330, 02350, 02490, 02356, 02496, 02410, 02430. Local anesthetic effect.

    FDA Enforcement
    Class II ·Terminated·Breg Inc·February 20, 2013

    BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.

    FDA Recall
    Terminated ·Breg Inc·Product code ILO·January 14, 2013

    BREG Cold Therapy Combination Units containing Sterile Polar Pads. 02356 Rev M, PAD M/U XL STER, Mfg.Date: 112012. Model #s: 10903, 10703, 09101, 09111, 09131, 09731, 09611, 09621, and 09631. Local anesthetic effect.

    FDA Enforcement
    Class II ·Terminated·Breg Inc·February 20, 2013

    V. Mueller Neuro/Spine, SHADOW-LINE, SPINAL DISTRACTION SCREW, STERILE, various sizes (12mm, 14mm, 16mm and 18mm) 5 PER BOX.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·October 19, 2016

    ARCHITECT STAT Troponin-I Reagent Kit; list numbers 2K41-28 (500 test kit); an in-vitro diagnostic test kit; each kit contains bottles of microparticles, conjugate and assay diluent; Abbott Laboratories, Abbott Park, IL 60064 ARCHITECT STAT Troponin-I is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of cardiac troponin-I in human serum and plasma on the ARCHITECT i System with STAT protocol capability. Troponin-I values are used to assist in the diagnosis of myocardial infarction (MI) and in the risk stratification of patients with acute coronary syndromes (including unstable angina and non-ST elevation) with respect to relative risk of mortality, myocardial infarction, or increased probability of ischemic events.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code MMI·April 11, 2012

    ACUSON SC2000 ultrasound systems at software versions VA20A or VA20B. Model number 10433816. The SC2000 ultrasound imaging system is intended for the following applications: Cardiac, Neo-natal and Fetal Cardiac, Pediatric, Transespohageal, Adult Cephalic, Peripheral Vessel, Abdominal, Abdominal Intraoperative, Intraoperative Neurological, Musculo-skeletal Conventional, and Musculo-skeletal Superficial applications.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·July 11, 2012

    Aplio 500/400/300 Diagnostic Ultrasound System (TUS-500/400/300). Device Listing Number: Dl53118. Diagnostic Ultrasound system.

    FDA Recall
    Terminated ·Toshiba American Medical Systems Inc·Product code ITX·December 11, 2012

    Rectal Retractors, titanium, item # AL07368000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code JAQ·April 12, 2012

    Rectal Retractors, stainless steel, item # AL07289000, a component of Varian Medical Ring and Tandem Applicator Sets; Intended for use in Brachytherapy.

    FDA Recall
    Terminated ·Varian Medical Systems, Inc.·Product code JAQ·April 12, 2012

    e.cam Emission Computed Tomography Systems. Siemens e.cam Emission Imaging Computed Tomography Systems is used for all common nuclear medicine procedures.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·May 15, 2012

    Symbia E is a multi-purpose SPECT system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·April 11, 2012

    Philips Easy Diagnost Product Usage: Stationary Fluoroscopic system

    FDA Recall
    Terminated ·Philips Healthcare Inc.·Product code IXR·May 11, 2012

    E.CAM emission computed tomography system used to detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomographic imaging for isotopes with energies up to 588 keV.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code KPS·April 11, 2012

    Model #03001-02: Periophil Biphasic, Synthetic Biphasic Dental Bone Graft Granules, 1.0 cc. Model # 03003-01 Periobase Biphasic: Periobase, Synthetic Biphasic Dental Bone Biphasic Granules, 0.5 cc. Model #03002-01: Periobone Biphasic, Synthetic HA/TCP Dental Bone Graft Biphasic Granules, 0.5 cc. Periophil Biphasic (synthetic grafting material) is intended for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. Cytophil, Inc., 2485 Corporate Circle, Suite 2, East Roy, WI 53120.

    FDA Recall
    Terminated ·Cytophil, Inc·Product code LYC·January 11, 2012

    Aesculap SIBD 4 degree Trial Implant (SJ768T-US) and Aesculap SIBD 9 degree Trial Implant (SJ780T-US) Product Usage: The Aesculap Implant Systems SIBD Trial Implant instruments assist the surgeon in selecting the correct size implant for the patient

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code HWT·July 12, 2012

    "***SENTINEL***Cannulated Drill Bit***S8580***8 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2012-03***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code HTW·April 10, 2012

    "***SENTINEL***Cannulated Drill Bit***S8585***8.5 X 229mm (9")***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***LOT***2009-02***". This drill bit is an eccentric mono-fluted cutting edge for drilling bone tunnels in ACL and PCL reconstruction.

    FDA Recall
    Terminated ·Linvatec Corp. dba ConMed Linvatec·Product code HTW·April 10, 2012

    Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample handling and processing in the clinical laboratory.

    FDA Recall
    Terminated ·Siemens Healthcare Diagnostics, Inc.·Product code JJE·October 11, 2012