BEUDAMED
    11 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 ×

    Terumo, Sarns Sternal Saw I System, Catalog 6090. The Sarns Sternal Saw I is indicated for use in splitting the sternum during thoracic surgery.

    FDA Recall
    Terminated ·Terumo Cardiovascular Systems Corporation·Product code DWH·November 17, 2011

    BIOMET StageOne, Shoulder Cement Spacer Mold 10 MM, 50 X 21 X 57 MM, Silicone, Sterile, Item 431410.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Boston Scientific (1) Flexima Regular Biliary Catheter System with RO Marker, 8 FR (2.7 mm) with Glidex hydrogel Coating Locking Pigtail and Radiopaque Marker, REF /Catalog No. 27-260 UPN; M001272600, Use before 2011-11, Sterilized with Ethylene Oxide Gas, Single Use Only, Made in USA 780 Brookside Drive, Spencer, IN 47460-1080. The catheter is designed for external and internal percutaneous drainage of the biliary system.

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code FGE·July 1, 2009

    Upgrade Kit, Resuscitation, T-Piece, part numbers M1139417, M1192226 and M1223628, labeled in part ***GE Healthcare 8880 Gorman Road Laurel, MD 20723 ***www.gehealthcare.com*** Provides the basic equipment required for pulmonary resuscitation of infants.

    FDA Enforcement
    Class II ·Terminated·GE Healthcare·February 12, 2014

    BIOMET StageOne, Shoulder Cement Spacer Mold 12 MM, 54 X 21 X 64 MM, Silicone, Sterile, Item 431412.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Alinity m System, Part No. 08N53-002

    FDA Enforcement
    Class II ·Terminated·Abbott Molecular, Inc.·January 12, 2022

    TOSHIBA Kalare Diagnostic X-Ray System K110785

    FDA Enforcement
    Class II ·Terminated·Toshiba American Medical Systems Inc·July 17, 2013

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·April 10, 2013

    BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.

    FDA Enforcement
    Class II ·Terminated·Biomet, Inc.·April 15, 2020

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012