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

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    KSEA MANHES TAKE-APART BIPOLAR COAGULATING FORCEPS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Pro-Flo XT™

    FDA UDI
    MEDTRONIC, INC.·00613994941473·CATH 010345 PF 10PK 6F 100 JL3.5 ST XT

    Zirlux

    FDA UDI
    HENRY SCHEIN, INC.·H65890103450·Zirlux 17 Degree Multi-Unit Abutment 2.5 mmH co...

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0103150·Shaver, Closed, 15mm

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345024106·Paddle Shaver, 15mm

    Liberty Anterior Cervical Plate

    FDA UDI
    VALORUS SPINE LLC·00811771030215·Cervical Plate, 3-level, 45mm

    INSTANT-VIEW PHENCYCLIDINE (PCP) URINE DIP STRIP TEST

    FDA 510(k)
    FDA Unclassified ·Unknown

    MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES

    FDA 510(k)
    FDA Class 2 ·Radiology

    FREESTYLE

    FDA Adverse Event
    Malfunction ·ABBOTT DIABETES CARE INC, USA·Product code LFR·May 11, 2007

    BHR

    FDA Adverse Event
    Injury ·SMITH & NEPHEW ORTHOPAEDICS LTD·Product code NXT·March 19, 2013

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·February 11, 2011

    DigitalDiagnost Classic 1.x Upgrades (Stitching Patient Support) 712081

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems Gmbh, DMC·August 29, 2018

    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

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013