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

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    PATRIOT PROTRUSIO CAGE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040038069·Channels K-Files 21mm, #25

    Safco Daily Plus Bibs

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·10810063752399·Safco Daily Plus bibs White, 500/case

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65820200761·Channels K-Files 21mm

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717100673·Earloop Masks Level 2 - Blue, Pkg/50

    Study Kit

    FDA UDI
    Cleveland Medical Devices Inc.·B14360200761·Single use study kit (compatible with thermistor).

    DYNA INTRA-LIMBAL LENS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CELL-CHEX

    FDA 510(k)
    FDA Class 2 ·Hematology

    FREESTYLE FLASH

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC.·Product code LFR·May 25, 2007

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·March 25, 2013

    SIG MOD TIB TRAY CEM COCR 4

    FDA Adverse Event
    Injury ·DEPUY-CORK A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·March 11, 2011

    MICROVASCULAR PLUG

    FDA Adverse Event
    Injury ·REVERSE MEDICAL·Product code KRD·March 25, 2022

    MICROVASCULAR PLUG

    FDA Adverse Event
    Injury ·REVERSE MEDICAL·Product code KRD·March 25, 2022

    Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.

    FDA Enforcement
    Class II ·Terminated·Belmont Instrument Corporation·October 24, 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

    Ultraview SL Command Modules, Model 91496-M, upgraded with the Masimo SpO2 Option. Product Usage: The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use. Physiological parameters that may be monitored include ECG with arrhythmia detection, respiration, invasive and noninvasive blood pressure, temperature, oxygen saturation (Sp02) and cardiac output. Acquired data may then be communicated to all information network for display, recording, editing and analysis.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 6, 2015