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

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    POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CMC

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427170·

    CMC

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427187·

    CMC

    FDA UDI
    FGX INTERNATIONAL INC.·00193033427163·

    QUANTA LITE GPA (GASTRIC PARIETAL CELL ANTIBODY) ELISA

    FDA 510(k)
    FDA Class 2 ·Immunology

    K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE

    FDA 510(k)
    FDA Class 2 ·Immunology

    SJM MECHANICAL HEART VALVE HEMODYNAMIC PLUS

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL PUERTO RICO, INC. (CS)·Product code LWQ·March 15, 2013

    CLINITRON AT-HOME

    FDA Adverse Event
    Injury ·HILL-ROM MANUFACTURING, INC.·Product code INX·February 28, 2011

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Injury ·AGA MEDICAL CORPORATION·Product code MLV·March 15, 2008

    Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; System, Imaging, Pulsed Doppler, Ultrasonic

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

    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020