BEUDAMED
    15 results · 28ms · Sources: EU EUDAMED, US FDA

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    D.O.R.C. CRYOSTAR CRYOSURGICAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673136·LEVAMED STABILI-TRI ANK SUP BLU L I

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0120210·Assembly, Screwdriver, Extended Tab, Cannulated...

    EYE SENTIAL

    FDA UDI
    FGX INTERNATIONAL INC.·00193033444702·

    ECHOSEED/IODINE-125 SEEDS, MODEL 6733

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO THE I.C.O.S SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·January 15, 2025

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 20, 2013

    PFC SIGMARP STB TB IN 4 10.0

    FDA Adverse Event
    Injury ·DEPUY (IRELAND)·Product code NJL·February 24, 2011

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·March 11, 2008

    COOLSCULPTING SYSTEM

    FDA Adverse Event
    Injury ·ALLERGAN PLEASANTON·Product code OOK·May 11, 2021

    Pinnacle Destination Guiding Sheath, 6 French, 90 cm, Straight Tip, Tuohy-Borst Valve, Lot MD24, MD31, ME07, & ME14. 510(k) K012812 Guiding Sheath is used to facilitate the introduction of interventional and diagnostic devices into the human vasculature, including but not limited to the renal arteries for the Renal Guiding Sheath and the carotid arteries for the Carotid Guiding Sheath.

    FDA Recall
    Terminated ·Terumo Medical Corporation·Product code DYB·June 24, 2010

    uNion Cervical Plate System Product Usage: The uNion Cervical Plate System is intended for anterior fixation of the cervical spine (C2 to Ti). The system is to be used to provide stabilization of the anterior cervical spine as an adjunct to fusion for the treatment of degenerative disc disease (defined as neck pain of discogenic origin with the degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fractures or dislocations), tumors, spinal stenosis, deformity (i.e., kyphosis, lordosis or scoliosis), pseudarthrosis or failed previous fusion.

    FDA Enforcement
    Class II ·Terminated·Ulrich Medical USA Inc·May 3, 2017

    Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    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