BEUDAMED
    57 results · 12ms · Sources: EU EUDAMED, US FDA

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    Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.

    FDA Enforcement
    Class II ·Terminated·Merit Medical Systems, Inc.·April 9, 2014

    Merit Custom Syringe Kit, Convenience Kit, I.R. Embolization Pack, K02-01010A, Sterile EO.

    FDA Recall
    Terminated ·Merit Medical Systems, Inc.·Product code FMF·March 13, 2014

    Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality.

    FDA Enforcement
    Class II ·Terminated·Abbott Point of Care Canada Limited·January 30, 2013

    Great Basin Staph lD/R Blood Culture Panel The Great Basin Staph lD/R Blood Culture Panel is a qualitative, multiplex in vitro diagnostic assay intended for use with the P4500 PortraitrM Analyzer System. The Staph lD/R Blood Culture Panel is capable of simultaneous detection and identification ol Staphylococcus aureus, Staphylococcus epidermidis, Staphylococcus lugdunensrs and various Staphylococcus species to the genus level and the detection of the mecA gene for methicillin resistance from patient positive blood culture specimens.

    FDA Enforcement
    Class II ·Terminated·Great Basin Scientific, Inc.·January 25, 2017

    Genesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.

    FDA Recall
    Terminated ·Keystone Dental Inc·Product code NHA·July 5, 2011

    Genesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.

    FDA Recall
    Terminated ·Keystone Dental Inc·Product code NHA·July 5, 2011

    Abbott Point of Care i-Stat cTnI cartridge. The i-Stat cardiac troponin I (cTnI) test is an in vitro diagnostic test for the quantitive measurement of cardiac troponin I (cTnI) in whole blood or plasma. Measurements of cardiac troponin I are used in the diagnosis and treatment of myocardial infarction and as an aid in the risk stratification of patients with acute coronary syndromes with respect to the relative risk of mortality.

    FDA Recall
    Terminated ·Abbott Point of Care Canada Limited·Product code MMI·November 1, 2012

    Solara Spree GT manual wheelchair.

    FDA Recall
    Terminated ·Invacare Corporation·Product code IOR·June 27, 2006

    Karma Flexx Wheelchair Manual Wheelchair.

    FDA Recall
    Terminated ·Karman Healthcare Inc·Product code IOR·January 27, 2016

    Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling chair. Used to assist injured and infirm people to walk or be ambulatory.

    FDA Recall
    Terminated ·Silver Star Brands·Product code IOR·October 10, 2014

    Manual Mechanical Wheelchair, 20'' seat, , maximum patient weight: 350 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in China; the wheelchairs were sold in the following configurations: reorder 16-7942: Removable Desk Arm, Swing Footrest reorder 16-7943: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7944: Removable Full Arm, Elevating Adjustable Legrest

    FDA Recall
    Terminated ·Cypress Medical Products, Ltd.·Product code IOR·May 3, 2004

    Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod Pediatric LT with Trailing Anti-Tipper-Caster-Axle Link, Freedom Designs Incorporated, Simi Valley, CA 93065

    FDA Recall
    Terminated ·Freedom Designs Inc·Product code IOR·May 14, 2007

    Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Kidster( Kidster). Product Usage: The purpose of these wheelchairs is to provide mobility to individuals limited to a seating position. They may also be used as attendant propelled transport devices in a health care environment such as a hospital, nursing home or extended care facility.

    FDA Recall
    Terminated ·Gunnell, Inc.·Product code IOR·November 1, 2011

    TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a component of the TiLite wheelchair (anti-tip extension for manual wheelchairs). Product Usage: The affected component is part of a manual wheelchair to provide mobility to physically impaired individuals. The affected component is used to prevent the wheelchair from tipping backwards.

    FDA Recall
    Terminated ·TiSport, Llc·Product code IOR·September 11, 2018

    Manual Mechanical Wheelchair, 18'' seat, , maximum patient weight: 250 lbs.; Marketed by McKesson Corporation, McKesson Medical-Surgical, Richmond, VA 23228, Made in China; the wheelchairs were sold in the following configurations: reorder 16-7901: Fixed Full Arm, Fixed Footrest reorder 16-7902: Fixed Full Arm, Swing Footrest reorder 16-7903: Fixed Full Arm, Elevating Adjustable Legrest reorder 16-7904: Removable Desk Arm, Swing Footrest reorder 16-7905: Removable Desk Arm, Elevating Adjustable Legrest reorder 16-7906: Removable Full Arm, Elevating Adjustable Legrest

    FDA Recall
    Terminated ·Cypress Medical Products, Ltd.·Product code IOR·May 3, 2004

    Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ14; Product is manufactured and distributed by Sunrise Medical (US) LLC., Fresno, CA. Used by a person to move from one place to another while sitting.

    FDA Recall
    Terminated ·Sunrise Medical (US) LLC·Product code IOR·November 11, 2013

    Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product Usage: The Crocodile is a walking aid for children with disabilities, who need supplementary assistance with their daily walking. The Crocodile is available in three sizes and can be used for children between the ages of 2 to 18 years.

    FDA Recall
    Terminated ·Snug Seat Inc·Product code IOR·August 26, 2013

    Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity; Manufactured in Taiwan for Medline Industries, Inc., Mundelein, IL 60060 USA; Item #MDS809600 comes with Removable Desk-Length Arms, Swing-Away Detachable Footrests, Fixed Height. item #MDS809650 comes with Removable Desk-Length Arms, Swing-Away Detachable Elevating Legrests, Fixed Height.

    FDA Recall
    Terminated ·Medline Industries Inc·Product code IOR·March 31, 2008

    Allegiance Laminated Wood Crutches, item 74151-040, Youth - 35'' - 43''; 1 pair individually shrink wrapped, 10 pairs per case; Distributed by Cardinal Health, McGaw Park, IL 60085-6787 USA, Made in China

    FDA Recall
    Terminated ·Duro-Med Industries, Inc.·Product code IPR·August 4, 2004

    Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Distributed by Invacare, Elyria, OH 44035 For transportation to accomplish necessary tasks of daily living in a home or community environment for the user.

    FDA Recall
    Terminated ·Invacare Corporation·Product code IOR·April 16, 2012