BEUDAMED
    15 results · 20ms · Sources: EU EUDAMED, US FDA

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    Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessory

    FDA 510(k)
    FDA Class 2 ·Radiology

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113455·SUPER SHARPS 15 DEG 5MM (BX/5)

    SPHYGMOCOR MX MODEL SCOR-MX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NASAL CEASE

    FDA 510(k)
    FDA Unclassified ·Unknown

    GENESIS II

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.·Product code HSH·October 17, 2008

    UNICEL® DXI 800 ACCESS IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·August 11, 2011

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013

    NCIRCLE TIPLESS STONE EXTRACTOR

    FDA Adverse Event
    Injury ·COOK INC·Product code FFL·July 20, 2017

    CENTRAL POST 7.0X25

    FDA Adverse Event
    Injury ·DEPUY IRELAND·Product code PHX·June 6, 2025

    ARCHITECT CA 19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code NIG·April 27, 2017

    ARCHITECT CA 19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code NIG·April 27, 2017

    ARCHITECT CA 19-9XR

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code NIG·April 27, 2017

    Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later).

    FDA Enforcement
    Class II ·Completed·Mako Surgical Corporation·November 25, 2020

    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

    Merlin PCS Programmer software model 3330, used with Confirm Rx Insertable Cardiac Monitor (ICM), Model DM3500, Sterile. The firm name on the label of the ICM is St. Jude Medical Cardiac Rhythm Management Division, Sylmar, CA. - Product Usage: The Confirm Rx insertable cardiac monitor is designed to detect arrhythmias and wirelessly transmit data to the Merlin.net Patient Care Network. The Confirm Rx ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical, Cardiac Rhythm Management Division·January 22, 2020