BEUDAMED
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    IDS-iSYS Ostase BAP

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113523·SLIT BLADE 3.0MM STR (BX/5)

    DESS dental smart solutions

    FDA UDI
    TERRATS MEDICAL SL.·08435457205654·Conical Bl

    CHEN IMPLANT ELEVATOR

    FDA UDI
    W.H. Holden, Inc.·D9282004750·

    Helical Ridge

    FDA UDI
    Medshape, Inc.·M97014002004750·4.75MM X 20MM PEEK Interference Screw

    CHAD THERAPEUTICS OXYPENUMATIC CYPRESS MODEL 511

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BRACHYSEED

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·October 8, 2014

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU·Product code FOZ·January 13, 2022

    STERIS SYSTEM 1E

    FDA Adverse Event
    STERIS CORPORATION - HOPKINS·Product code MED·October 24, 2014

    PROXIMATE** RELOADABLE LINEAR CUTTER WITH SAFTEY LOCK-OUT

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 11, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 1, 2013

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL·Product code MLV·May 22, 2023

    AMPLATZER SEPTAL OCCLUDER

    FDA Adverse Event
    Malfunction ·ABBOTT MEDICAL·Product code MLV·May 22, 2023

    PROXIMATE*HCS HEMORR CIR STAPL (EXACT CODE UNKNOWN

    FDA Adverse Event
    Injury ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·August 5, 2019

    Spacelabs Medical Patient Monitor is a Physiological, Patient monitor With Arrhythmia Detection or Alarms. The Models are 91367, 91369, 91370, 91387, and 91393 are sold with Perioperative Mode (option D), which includes Start case/End case functionality, Upgrade Kit 040-1548-00. Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the models 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·October 1, 2014

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    Exactech Equinoxe REVERSE SHOULDER,36mm Humeral Liner: a) +0mm, Item Number 320-36-00, b) +2.5mm, Item Number 320-36-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024