BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    ELECSYS PROBNP II STAT IMMUNOASSAY AND ELECSYS PROBNP II CALSET, MODELS 05390109-160, 04842472-190

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ARAMIS DERMATOLOGICAL LASER

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

    RAICHEM BUN RATE REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPECTRA OPTIA

    FDA Adverse Event
    TERUMO BCT·Product code LKN·May 3, 2013

    MALLINCKRODT

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code BTS·August 19, 2014

    ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code NIQ·May 10, 2011

    COOK-SWARTZ DOPPLER PROBE

    FDA Adverse Event
    Injury ·COOK VASCULAR INC·Product code ITX·September 6, 2015

    1.5MM DIA DRILL BIT W/6MM STOP 13MM LENGTH F/90° SCREWDRIVER

    FDA Adverse Event
    Injury ·SYNTHES SELZACH·Product code DZI·May 19, 2015

    BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·November 21, 2019

    BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·December 23, 2019

    DPM 6/7 Patient Monitor Manufactured in China for : Mindray DS USA, Inc. 800 MacArthur Blvd. Mahwah, NJ 07430 USA. Intended to be used for monitoring, displaying, reviewing, storing and alarming of multiple physiological parameters including ECG (3-lead or 5-lead or 12-lead selectable). arrhythmia detection, ST Segment analysis, heart rate (HR) , respiration rate (RESP), temperature (TEMP), pulse oxygen saturation (SpO2), pulse rate (PR), non-invasive blood pressure (NIBP), invasive blood pressure (IBP), carbon dioxide (CO2), anesthetic gas (AG),impedance cardiograph (ICG), bispectral index (BIS), cardiac output (C.O.) and respiration mechanics (RM).

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·December 19, 2012

    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

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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