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

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    PC-180 / PRINCE 180 EASY ECG MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NOBELREPLACE CC PMC RP 4.3X10MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE USA INC·Product code DZE·June 15, 2021

    NOBELPARALLEL CC NP 3.75X13MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·March 8, 2021

    NOBELPARALLEL CC NP 3.75X13MM

    FDA Adverse Event
    Injury ·NOBEL BIOCARE AB·Product code DZE·March 8, 2021

    SOMATOM SMILE

    FDA 510(k)
    FDA Class 2 ·Radiology

    ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    WAVEWRITER ALPHA

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·February 6, 2023

    STEM: QUADRA-H CEMENTLESS, HA COATED STD SIZE1

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JDI·May 6, 2021

    GLIDEWIRE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION, ASHITAKA·Product code DQX·April 23, 2013

    TAPE WATERPROOF 1IN

    FDA Adverse Event
    Product code KGX·April 29, 2011

    ATLAS II PLUS DR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·July 11, 2008

    Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015

    Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·May 20, 2015

    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