BEUDAMED
    12 results · 29ms · Sources: EU EUDAMED, US FDA

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    AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MiniKut

    FDA UDI
    DENTAL ENGINEERING LABORATORIES, LLC·00850001745604·MiniKut EZ Rotary NiTi Endodontic Files .15/.03...

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189706·LEVAMED ACTIVE ANKLE SUP BLACK L I

    ORTHO VLC; ORTHO VLC CAPSULE

    FDA 510(k)
    FDA Class 2 ·Dental

    SOFTSENS

    FDA 510(k)
    FDA Class 2 ·Neurology

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·April 2, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·August 22, 2014

    INTERSTIM II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·March 25, 2011

    DYNESYS LIS, STABILIZING CORD, 200

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code NQP·May 2, 2019

    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

    The Spirit Select Bed, Model 5700 Spirit Plus /with high rail siderail option

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·November 21, 2018

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. 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