BEUDAMED
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    PERI-LOC PERIARTRICULAR LCK PIT SYS-PROX FEM PLATES/SCREWS.CALBE ACCESS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Integra® Spider™ Limted Wrist Fusion System

    FDA UDI
    Ascension Orthopedics, Inc.·10381780064862·The Integra Spider Limited Wrist Fusion bone sc...

    Spider Limited Wrist Fusion System

    FDA UDI
    Smith & Nephew, Inc.·00885556834831·SPIDER 2.8MM SCREW 18MM L

    LINEAR ST

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 6, 2020

    NIRTRILE PATIENT EXAMINATION GLOVE (BLUE COLOR) POWDERED, NON STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 27, 2025

    THERAKOS PHOTOPHERESIS

    FDA Adverse Event
    Injury ·THERAKOS, INC·Product code LNR·April 17, 2013

    CS100

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·March 31, 2011

    CAPSURE Z NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DXY·July 10, 2008

    LOCATOR Implant Attachment System. The LOCATOR Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Recall
    Terminated ·Zest Anchors LLC·Product code DZE·January 16, 2014

    LOCATOR¿ Implant Attachment System. The LOCATOR¿ Implant Attachment System is a universal hinge, resilient attachment for endosseous implants. The LOCATOR¿ Implant Attachment System is designed for use with overdentures or partial dentures, retained in whole or in part, by endosseous implants in the mandible or maxilla. FDA 510(k): K994257, K072878

    FDA Enforcement
    Class II ·Terminated·Zest Anchors LLC·February 12, 2014

    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