BEUDAMED
    18 results · 20ms · 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.

    MODIFICATION TO:FASTIX THC/COC DRUG SCREEN DIPSTICK TEST, FASTIX THC/COC/MET DRUG SCREEN DIPSTICK TEST, FASTIX OPI/MET

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450278031·

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH INC.·Product code QJR·January 11, 2021

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033426463·

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427033·

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033426456·

    NINE WEST

    FDA UDI
    FGX INTERNATIONAL INC.·00193033426470·

    PROTEIN C REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    PREVISION CHEM

    FDA 510(k)
    FDA Class 2 ·Dental

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·May 8, 2018

    GRAFTMASTER RX CORONARY STENT GRAFT SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT VASCULAR·Product code MAF·December 15, 2021

    SJM MECHANICAL HEART VALVE W/TEFLON CUFF

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, PUERTO RICO, INC. (CS)·Product code LWQ·March 15, 2013

    GORE HYBRID VASCULAR GRAFT

    FDA Adverse Event
    Injury ·W.L. GORE & ASSOCIATES·Product code DSY·February 28, 2011

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MZO·August 15, 2014

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·May 22, 2018

    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

    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

    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020