BEUDAMED
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    MICROTHIN-PI BIPOLAR PULSE GENERATOR

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Bardia® Urethral Catheter

    FDA UDI
    C. R. Bard, Inc.·00801741018336·Bardia® Urethral Catheter - Red Rubber

    BOSS Instruments

    FDA UDI
    BOSS INSTRUMENTS, LTD., INC.·00888515209824·Jameson Caliper

    FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MASTER3DS

    FDA 510(k)
    FDA Class 2 ·Radiology

    UNKNOWN METAL COMPONENT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·February 25, 2026

    NV GXL LNR, +5LAT, 36MM G2-52/54MM CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·February 25, 2026

    NOVATION HIP COMPONENTS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·February 25, 2026

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DXE·November 27, 2024

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES PR·Product code DXE·February 4, 2026

    HEARTSTART FR3 ECG, BASIC BUNDLE, EUROPE

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·February 21, 2014

    PLUM 1.6 W/DATAPORT

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·October 18, 2012

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 28, 2015

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXE·March 13, 2025

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES, PR·Product code DXE·September 5, 2025

    FOGARTY

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DXE·February 11, 2025

    ACUSON Sequoia Ultrasound Imaging System with Software Version VA25A/B

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc.·February 9, 2022

    Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number 314-01-02; b) Medium, Item number 314-01-03; c) Large, Item Number 314-01-04, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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