BEUDAMED
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    EMIT(R) II CALIBRATOR LEVEL 0 (NEGATIVE)

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    ALLthread Titanium

    FDA UDI
    Biomet Orthopedics, LLC·00880304464193·

    5.0MM TITANIUM SCREW ANCHOR WITH NEEDLES

    FDA Adverse Event
    Malfunction ·BIOMET SPORTS MEDICINE·Product code HWC·October 11, 2016

    MITS DICOM GATEWAY AND IMAGE MANAGER

    FDA 510(k)
    FDA Class 2 ·Radiology

    DURAGARD SODIUM FLUORIDE VARNISH

    FDA 510(k)
    FDA Class 2 ·Dental

    5.0MM TI W/ MAXBRAID NDLS

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·February 9, 2022

    TERUMO ADVANCED PERFUSION SYSTEM 1

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DTQ·May 9, 2014

    PROMOTE PLUS CRT-D

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NIK·January 8, 2013

    DEXTRUS 4136

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG·Product code NVZ·November 12, 2010

    STOPCOCK MANIFOLD GANGS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FMG·June 17, 2020

    5.0MM TI W/ MAXBRAID NDLS

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code HWC·February 9, 2022

    CPT FEMORAL STEM 12/14 NECK TAPER EXT. OFFSET SIZE 0 105 MM STEM LENGTH

    FDA Adverse Event
    Injury ·ZIMMER MANUFACTURING B.V.·Product code JDI·May 31, 2024

    Beckman Coulter UniCel DxI 600, Part Numbers: A71460, A30260; Photometric Chemistry Analyzer

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·November 12, 2025

    DxI 600 Access Immunoassay Analyzer W/Spot B, Part Number A71460

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·August 13, 2025

    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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025