BEUDAMED
    104 results · 11ms · 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 ×

    Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonstration of yeast and fungal elements in wet clinical preparations. Potassium Hydroxide digests the proteinaceous material in the specimen, leaving the fungal cell wall intact for direct microscopic observation.

    FDA Recall
    Terminated ·Gibson Bioscience·Product code JTO·July 1, 2021

    Potassium Hydroxide 10% (KOH 10%), Cat. No. 300145 Potassium Hydroxide 10% (KOH 10%) is intended for use in the demonstration of yeast and fungal elements in wet clinical preparations. Potassium Hydroxide digests the proteinaceous material in the specimen, leaving the fungal cell wall intact for direct microscopic observation.

    FDA Enforcement
    Class II ·Terminated·Gibson Bioscience·September 22, 2021

    ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

    FDA Recall
    Terminated ·Aesculap Implant Systems LLC·Product code LXH·July 13, 2020

    Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use.

    FDA Recall
    Terminated ·Abbott Laboratories·Product code JJE·May 11, 2015

    Alkaline Wash, List number 9D31-20, a cleaning solution used by the Abbott Architect analyzers. It is supplied in 500 mL bottles and contains NaOCl, NaOH, and KOH. It is shipped and stored at room temperature and is shipped ready to use.

    FDA Enforcement
    Class II ·Terminated·Abbott Laboratories·June 17, 2015

    BariAir AC-Powered Adjustable Hospital Beds

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code IOQ·April 11, 2000

    Flexicair MC3 (model M4000) Low Airloss Therapy Units, for the prevention of pressure sores.

    FDA Recall
    Terminated ·Hill-Rom Manufacturing, Inc.·Product code IOQ·May 12, 2009

    BF-3C40 OES Bronchofiberscope, Model No. BF-3C40

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 16, 2021

    EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 17, 2021

    Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH 90 cm x 1.9 mm Product Code: 58229 19US

    FDA Recall
    Terminated ·Prodimed Plastimed Division 3 Rue Louis Armand Le Plessis Bouchard France·Product code EOQ·May 27, 2020

    IsoFlex LAL Support Surface, Model Number 2860 Product Usage: : The IsoFlex LAL support surface assists in the prevention and treatment of all pressure injuries (including stages 1,2,3,4, unstageable injury, and deep tissue injury) and is recommended to be implemented in combination with clinical evaluation of risk factors and skin assessments made by a health care professional. This support surface is for use with human patients with existing or at risk of incurring pressure injuries. The patient must not exceed the safe working load as specified by the support surface. A healthcare professional should determine the use of this support surface by patients outside of the therapeutic weight range. The minimum patient age requirement for this support surface is two years. IsoFlex LAL shall be used with a support surface cover at all times. The support surface cover can interact with all external skin. This support surface is for use by patients in an acute care setting. This may include critical care, step down, progressive care, med/surg, subacute care, and post anesthesia care unit (PACU), or other locations as prescribed by a physician. Operators of this support surface include healthcare professionals (such as nurses, nurse aids, or doctors). IsoFlex LAL support surface is not intended to: be used in a home health environment setting be used as a sterile product include a measuring function be used with a patient less than two years of age Stryker promotes the clinical assessment of each patient and appropriate usage by the operator.

    FDA Recall
    Terminated ·Stryker Medical Division of Stryker Corporation·Product code IOQ·August 13, 2018

    Bronchofiberscope BF-40

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018

    Bronchovideoscope BF-Q180-AC

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018

    Bronchovideoscope F-1TQ180

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018

    Ultrasonic Bronchoscope BF-UC160F-OL8

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018

    Bronchofiberscope BF-XP60

    FDA Recall
    Terminated ·Olympus Corporation of the Americas·Product code EOQ·August 8, 2018

    K-201 GUIDE SHEATH Kit 2.0MM, model no. K-201 - Product Usage: Used with endoscopes to collect cells or tissue specimens in the respiratory organs.

    FDA Recall
    Terminated ·Aomori Olympus Co., Ltd. 2 Chome 248-1 Okkonoki Kuroishi Japan·Product code EOQ·January 4, 2021

    PediDyne AC-Powered Adjustable Hospital Beds

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code IOQ·April 11, 2000

    EP-4 Computerized Cardiac Stimulator; SJM Part Numbers: 09-1527-0000 / 09-1527-0002; EP MedSystems, Inc. 575 Route 73 North, Units D, West Berlin, NJ 08091. Indicated for use during clinical electrophysiology procedures.

    FDA Recall
    Terminated ·St. Jude Medical·Product code JOQ·March 23, 2009

    KCI Underbed Inverter, Accessory to Powered Flotation Therapy Bed, manufactured by Kinetic Concepts, Inc., San Antonio, TX. Model number 201189

    FDA Recall
    Terminated ·Kinetic Concepts, Inc·Product code IOQ·March 22, 2004