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

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    ECAT ACCEL PET SCANNER

    FDA 510(k)
    FDA Class 2 ·Radiology

    Custom Procedure Kit

    FDA UDI
    MEDIVATORS INC.·40677964019324·Endo Carry-On Procedure Kit

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·10304040054786·Strip Crown Forms

    G-CEM™

    FDA UDI
    Gc America Inc.·14548161282253·G-CEM™ A2, box of 50 capsules

    G-CEM™

    FDA UDI
    Gc America Inc.·D0470025841·G-CEM™ A2, box of 50 capsules

    METROFOCAL TORIC (HIOXIFILCON A) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    CARDIOSAVE HYBRID, TYPE B PLUG

    FDA Adverse Event
    Malfunction ·DATASCOPE CORP.·Product code DSP·June 17, 2025

    NAVILYST MEDICAL /XCELA

    FDA Adverse Event
    Malfunction ·NAVILYST MEDICAL·Product code LJS·February 13, 2013

    HIRES 90K

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS, LLC·Product code MCM·February 4, 2011

    IAB : 8 FR - 30 CC

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code DSP·February 8, 2008

    ARIATELE TELEMETRY TRANSMITTER, Model 96281, with SpO2 Option C. Model 96281 is intended for use with either adult or neonatal patient populations in a hospital environment.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·February 5, 2014

    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

    1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: Flex Focus 200, Flex Focus 300, Flex Focus 400, Flex Focus 500, Flex Focus 700, Flex Focus 800; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    Thoratec HeartMate 3 LVAS Implant Kit, Rx Only, Catalog # 106524US, 106524, 10652INT - LVAS KIT, HM 3 Indicated for providing short-term hemodynamic support in patients with advanced refractory left ventricular heart failure.

    FDA Enforcement
    Class I ·Terminated·Abbott·May 23, 2018

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

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