BEUDAMED
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    METRX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    METRX SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code HRX·June 10, 2024

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169328709·TEMPLATE 3002931 ZEVO 31MM 2 LVL

    Surgical Direct

    FDA UDI
    Surgical Direct, Inc.·B382SD770029310·11 1/2 Reueable Bowel Sizer, 31 x 33mm, Solid B...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180161856·REUSABLE BOWEL SIZER, 31 X 33MM SOLID BARREL SH...

    WAKO AUTOKIT LP(A) & LP(A) CALIBRATOR/AEROSET

    FDA 510(k)
    FDA Class 2 ·Immunology

    AU5 ULTRASOUND IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    GMK SPHERE TOTAL KNEE SYSTEM

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·October 28, 2024

    GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE 4 L

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·March 24, 2022

    XIENCE PRO EVEROLIMUS ELUTING RX CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·March 13, 2013

    PINNMAR +4 NEUT 32IDX56OD

    FDA Adverse Event
    Injury ·DEPUY ORTHOPEDICS, INC.·Product code LPH·February 16, 2011

    ICY HOT HEAT THERAPY PATCH

    FDA Adverse Event
    Other ·CHATTEM, INC.·Product code IMD·February 8, 2008

    CS100 INTRA-AORTIC BALLOON PUMP, ITALIAN, 220V

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·July 9, 2025

    Natus neoBLUE blanket LED Phototherapy system, neonatal phototherapy. Used to provide treatment for neonatal Hyperbilirubinemia. 006224 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad 006254 neoBLUE blanket LED Light Box 006895 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad 007299 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad EUR 007300 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad EUR 007296 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad UK 007298 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad UK 007301 neoBLUE blanket LED Phototherapy Systems with Large blanket/pad AUS 007296 neoBLUE blanket LED Phototherapy Systems with Small blanket/pad AUS

    FDA Enforcement
    Class II ·Terminated·Natus Medical Incorporated·December 21, 2016

    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

    Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly

    FDA Enforcement
    Class II ·Ongoing·Covidien·August 28, 2024