BEUDAMED
    19 results · 19ms · Sources: EU EUDAMED, US FDA

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    TOURNIQUET CUFF; PNEUMATIC TOURNIQUET

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04047872673181·LEVAMED STABILI-TRI ANK BLU R II

    Omnilink Elite

    FDA UDI
    ABBOTT VASCULAR INC.·08717648178542·Omnilink Elite Vascular Balloon-Expandable Sten...

    Omnilink Elite

    FDA UDI
    ABBOTT VASCULAR INC.·08717648178566·Omnilink Elite Vascular Balloon-Expandable Sten...

    Omnilink Elite

    FDA UDI
    ABBOTT VASCULAR INC.·08717648178559·Omnilink Elite Vascular Balloon-Expandable Sten...

    Omnilink Elite

    FDA UDI
    ABBOTT VASCULAR INC.·08717648178535·Omnilink Elite Vascular Balloon-Expandable Sten...

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450286289·

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code NIO·April 1, 2022

    OMNILINK ELITE PERIPHERAL STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code NIO·April 1, 2022

    ID NOW COVID-19 ASSAY

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·January 20, 2021

    OXYGENATOR

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

    BUTTERFLY PLATE FUNCTION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VECTORVISION FLUORO 3D

    FDA Adverse Event
    Other ·BRAINLAB AG·Product code HAW·March 15, 2013

    PROXIMATE** SKIN STAPLER 35 WIDE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDT·March 10, 2011

    PHILIPS INFORMATION CENTER

    FDA Adverse Event
    Injury ·PHILIPS MEDICAL SYSTEMS·Product code DRT·March 11, 2008

    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

    StimQ Peripheral Nerve Stimulator System (PNS) Model STQ4-SPR-BO US - Product Usage: is used for peripheral neural stimulation to provide therapeutic relief for chronic, intractable pain of peripheral nerve origin. The therapy utilizes pulsed electrical current to create an electrical energy field that acts on peripheral nerves in the limbs and torso to alter the transmission of pain signals to the brain.

    FDA Enforcement
    Class II ·Ongoing·Stimwave Technologies Inc·September 9, 2020

    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