BEUDAMED
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    PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT

    FDA 510(k)
    FDA Class 2 ·Dental

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450308028·

    QUO

    FDA UDI
    FGX INTERNATIONAL INC.·00193033442975·

    QUO

    FDA UDI
    FGX INTERNATIONAL INC.·00057800204947·

    INSET II

    FDA Adverse Event
    Injury ·UNOMEDICAL DEVICES S.A. DE C.V.·Product code FPA·December 31, 2025

    WAVEWRITER ALPHA PRIME

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·September 11, 2024

    BRIDGE III RECEIVER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MODEL 5000 MULTIPLACE HYPERBARIC THERAPY

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    0009613348-2024-012794

    FDA Adverse Event
    Injury ·INSTITUT STRAUMANN AG·Product code DZE·September 26, 2024

    SYSTEM, PERITONEAL AUTOMATIC DELIVERY

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

    ASR ACETABULAR CUPS 54

    FDA Adverse Event
    Injury ·DEPUY INT'L LTD·Product code KWA·February 24, 2011

    TERUMO CENTRIFUGAL SYSTEM

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP·Product code KFM·March 12, 2008

    GMK PRIMARY TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 31, 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

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - 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