BEUDAMED
    18 results · 23ms · Sources: EU EUDAMED, US FDA

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    BONART ART-E1 ELECTROSURGERY UNIT

    FDA 510(k)
    FDA Class 2 ·Dental

    Henry Schein

    FDA UDI
    HENRY SCHEIN, INC.·H65820200801·Channels K-Files 21mm

    Affiniti™ EH²

    FDA UDI
    TORNIER, INC.·00846832002207·

    Safco Air/Water Syringe Tips

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·D72310200803·Safco air/water syringe tips, assorted colors, ...

    Channels

    FDA UDI
    HENRY SCHEIN, INC.·10304040038113·Channels K-Files 21mm, #15-40

    Midway Select

    FDA UDI
    MIDWAY DENTAL SUPPLY, LLC·10843717100710·Earloop Masks Level 3 - Blue, Pkg/50

    Santis Straight Rod 5.5mmx80mm

    FDA UDI
    Lanterna Medical Technologies GmbH·07640159550747·Santis Straight Rod 5.5mmx80mm

    SANTIS™ STRAIGHT ROD 5.5mm X 80mm -STERILE

    FDA UDI
    Lanterna Medical Technologies GmbH·07640159551867·SANTIS™ STRAIGHT ROD 5.5mm X 80mm -STERILE

    ASNIS III CANNULATED SCREW SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BEHRING COAGULATION SYSTEM, MODEL BCS

    FDA 510(k)
    FDA Class 2 ·Hematology

    FREESTYLE

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

    ICL (IMPLANTABLE COLLAMER LENS)

    FDA Adverse Event
    Injury ·STAAR SURGICAL COMPANY·Product code MTA·March 25, 2013

    TRANSTAR STRETCHER

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FPO·March 10, 2011

    1.85MM TI MATRIX SCREW SELF-TAPPING/4MM

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code JEY·January 21, 2015

    EverFlex Self-Expanding Peripheral Stent with Entrust Delivery System

    FDA Enforcement
    Class II ·Ongoing·Medtronic Inc.·September 7, 2022

    SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2

    FDA Enforcement
    Class II ·Ongoing·Baxter Healthcare Corporation·January 28, 2026

    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