BEUDAMED
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    DIASCREEN REAGENT STRIPS FOR URINALYSIS, MODELS D122OO (2GK), D12100 (1K), D11100 (1G)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Baltic Denture System BDLoad

    FDA UDI
    Merz Dental GmbH·D7091033851·Baltic Denture System BDLoad BDLoad ↓ Sm7 PLSEu...

    PRECIMED HIP SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1119

    FDA 510(k)
    FDA Class 2 ·Immunology

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 23, 2006

    KYPHX HV-R BONE CEMENT

    FDA Adverse Event
    Injury ·KYPHON, INC.·Product code NDN·June 20, 2006

    RENU WITH MOISTURELOC MULTIPURPOSE SOLUTION

    FDA Adverse Event
    Injury ·BAUSCH & LOMB INCORPORATED·Product code LPN·February 18, 2020

    WATCHMAN ACCESS SYSTEM

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code NGV·April 10, 2024

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FKX·April 3, 2013

    REPLY

    FDA Adverse Event
    Malfunction ·SORIN CRM S.R.L.·Product code NVZ·February 11, 2011

    PREMIUM PLUS CEEA 31 INSTR. W/TILT-TOP

    FDA Adverse Event
    Injury ·PONCE - USS·Product code GDW·April 24, 2008

    Medfusion Model 4000 Syringe Infusion Pump, with software versions V1.6.0 or V1.6.1 that have implemented the Smart Pump Programming (SPP) feature in a clinical treatment environment. Used for infusion of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions, and other therapeutic fluids.

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·November 30, 2022

    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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024