BEUDAMED
    14 results · 26ms · Sources: EU EUDAMED, US FDA

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    MODIFICATION TO HYBRID CAPTURE 2 GC-ID DNA TEST, MODEL 03M92-01

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Endo Carry-on Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964152597·Endo Carry-on Procedure Kit contains Intercept ...

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526743601·LEVAMED ANKLE SUPPORT SAND III

    MEDTRONIC EXTENDED

    FDA Adverse Event
    Injury ·UNOMEDICAL A/S·Product code FPA·May 15, 2025

    ULTRACISION SURG, DEV, BLADES 5MM OPEN

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code LFL·June 16, 2006

    WHITE KNIGHT MASKS, BLUE, PINK, YELLOW, WHITE MASKS (13 MODELS)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    AC POWERED THERMAL CAUTERY UNIT

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TORRENT IRRIGATION TUBING

    FDA Adverse Event
    Malfunction ·UNITED STATES ENDOSCOPY GROUP, INC.·Product code GCJ·March 14, 2013

    SMARTSITE

    FDA Adverse Event
    Malfunction ·CAREFUSION·Product code FPA·February 25, 2011

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2008

    MENTOR SMOOTH ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·December 14, 2022

    ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The Arrow OnControl Bone Marrow Aspiration System is intended for bone marrow aspiration of the iliac crest of adult and pediatric patients. The Arrow¿ OnControl Bone Marrow Biopsy System is intended for bone marrow core biopsy of the anterior or posterior iliac crest of adult patients

    FDA Enforcement
    Class II ·Terminated·Teleflex Medical·December 7, 2016

    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

    Medfusion¿ Model 4000 Syringe Infusion Pump, with PharmGuard¿ Server Software (PGS). Sold under the following names: MEDFUSION¿ 4000 Pump V1.0; MEDFUSION¿ 4000 Pump V1.1, v1.1.1, v1.1.2; MEDFUSION¿ 4000 Pump V1.1, V1.1.1, V1.1.2; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.5, V1.5.1; MEDFUSION¿ 4000 Pump V1.6, V1.6.1 Product Usage: The pumps are indicated for the following uses: 1. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids; 2. By the following delivery routes: arterial, epidural, intravenous, intrathecal, subcutaneous, and enteral; 3. By the following delivery modes: continuous, volume/time, mass, body weight, intermittent and bolus.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD Inc.·October 2, 2019