BEUDAMED
    19 results · 21ms · Sources: EU EUDAMED, US FDA

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    VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM

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

    "2.4MM" FRACTURE SYSTEM TWIST DRILL

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036009441·

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450278086·

    DENALI Spinal System

    FDA UDI
    VB Spine LLC·10888857241824·Provisional Screwdriver

    VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDILOG EXCEL 2 - HOLTER MANAGEMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    H 105700#TUBING SET

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·May 5, 2015

    HQV 32902#INTEGRATED ADULT PACK

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DWE·June 22, 2015

    BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO., (BD)·Product code FMI·December 6, 2017

    FEMOSTOP

    FDA Adverse Event
    Malfunction ·RADI MEDICAL SYSTEMS, INC.·Product code MGB·November 21, 2003

    VERTEBRAL BODY SPREADER- ANGLED

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HTD·March 20, 2013

    ADVIA CENTAUR XP

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MOI·August 15, 2014

    DLT TS CER HD 12/14 40MM +8.5

    FDA Adverse Event
    Injury ·DEPUY INT'L., LTD.·Product code LZO·February 24, 2011

    FEMOSTOP

    FDA Adverse Event
    Injury ·RADI MEDICAL SYSTEMS·Product code DXC·August 20, 2003

    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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2110. Indicated for the following uses: Intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site, epidural space or subarachnoid space. Therapies that require a continuous rate of infusion, intermittent bolus, and/or with patient-controlled demand doses.

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·August 14, 2024

    Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018

    StimQ Peripheral Nerve Stimulator System (PNS) Model 1. STQ4-RCV-A0 US and 2.STQ4-RCV-A0 EU - 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