BEUDAMED
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    PROTEMP 3 GARANT

    FDA 510(k)
    FDA Class 2 ·Dental

    Baltic Denture System BD Load

    FDA UDI
    Merz Dental GmbH·D7091033022·Baltic Denture System BDLoad Mn7 PLSEbim6DFm C4...

    Hayden Medical

    FDA UDI
    Hayden Medical, Inc.·00840319701270·Keyes Dermal Biopsy Punch 4" (10cm), 3mm, stain...

    CosmoLock Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07311K0360220·Probe, Modified AO, Steffee, Curved

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K0380220·Handle, Threaded Large Dynamo Impact

    Universa

    FDA UDI
    COOK INCORPORATED·00827002532441·Universa, Silicone Foley Catheter 3-Way Open-End

    Universa

    FDA UDI
    COOK INCORPORATED·00827002532373·Universa, Silicone Foley Catheter 3-Way Closed End

    TRILOGY EV300

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code CBK·February 4, 2022

    SULZER VASCUTEK GELWEAVE VALSALVA VASCULAR PROSTHESIS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AERONEB PORTABLE NEBULIZER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    NEXUS HELIX SUPER SOFT CSR DETACHABLE COIL

    FDA Adverse Event
    Malfunction ·EV3 NEUROVASCULAR·Product code HCG·April 3, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·August 25, 2014

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·April 22, 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

    Smiths Medical Medfusion Model 4000 Syringe pump, Item Numbers: a) 4000-0101-249, b) 4000-0101-50, c) 4000-0101-51, d) 4000-0105-249, e) 4000-0105-50, f) 4000-0105-51, g) 4000-0105-78, h) 4000-0106-00, i) 4000-0106-01, j) 4000-0106-231,

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·April 24, 2024

    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