BEUDAMED
    27 results · 26ms · Sources: EU EUDAMED, US FDA

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    MASIMO LNCS/M-LNCS OXIMETRY SENSORS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    LNCS DC-I

    FDA Adverse Event
    Malfunction ·MASIMO - 40 PARKER·Product code DQA·March 11, 2017

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964070822·The ENDO CARRY-ON Procedure Kit contains all of...

    GYRUS ACMI HALO PKS CUTTING FORCEPS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS; KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Widex

    FDA UDI
    Widex A/S·05706069773279·Widex EVOKE E-PA, RC coil

    TARGETING ARM PROX. LAT. TIBIA LEFT

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·February 2, 2012

    UNKNOWN PLATE

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·April 21, 2026

    UNKNOWN PLATE

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·April 21, 2026

    UNKNOWN PLATE

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·April 21, 2026

    DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTO·May 9, 2013

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code NIQ·September 19, 2014

    UNICEL DXC 800 PRO INSTRUMENT

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·April 29, 2011

    STERNALOCK BLU SYSTEM BLADE, STERNALOCK POWERDRIVER

    FDA Adverse Event
    Malfunction ·BIOMET MICROFIXATION·Product code HRS·January 10, 2019

    Non-Rebreather Mask w 7 (2.1 m) No-Crush Tubing, Adult, Product Code 9106-E, Product Code 9108-E, Product Code ZRNRMA

    FDA Enforcement
    Class II ·Terminated·ConvaTec, Inc·June 14, 2017

    AirFlow, Small Adult Resuscitator, AF5000 Series, Single use, Manufactured by: Ventlab Corporation, 155 Boyce Drive, Mockville, NC 27028 The Disposable Resuscitators with optional built-in pressure monitor is intended to provide respiratory support in the presence of reversible apnea, commonly associated with cardiopulmonary arrest.

    FDA Enforcement
    Class I ·Terminated·Ventlab Corporation·November 7, 2012

    Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000

    FDA Enforcement
    Class I ·Ongoing·Covidien·November 8, 2023

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Model Number L231, PROPONENT DR EL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025