BEUDAMED
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    ALGO 3I NEWBORN HEARING SCREENER

    FDA 510(k)
    FDA Class 2 ·Neurology

    Hern Dilator

    FDA UDI
    MEDGYN PRODUCTS, INC.·M803030823·Hern Dilator 89Fr (29.6 mm)

    Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)

    FDA UDI
    TENON MEDICAL, INC.·B74240308230·10mm Extraction Fork

    8 x 23mm Citrelock ACL Implant

    FDA UDI
    Acuitive Technologies, Inc.·00810027270597·

    DRACO

    FDA UDI
    HNM TOTAL RECON LLC·00841742121918·DRACO MetaFuse Midfoot/Lisfranc Plate, Ti - (L)...

    SCS DT-02 TRANSVERSE CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SPAZZ

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·February 5, 2025

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.·Product code CBK·March 27, 2013

    840 VENTILATOR

    FDA Adverse Event
    Injury ·COVIDIEN-NELLCOR AND PURITAN BENNETT·Product code CBK·March 23, 2011

    FLO-GARD 6201 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE (SG)·Product code FRN·April 17, 2008

    Intra operative MRI Systems: Neuro II-SE , Neuro III-SV, iMRI 1.5T A, and iMRI 3T S. Indicated for use as a magnetic resonance diagnostic device (MRDD).

    FDA Enforcement
    Class II ·Terminated·Deerfield Imaging·March 23, 2016

    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