BEUDAMED
    18 results · 20ms · Sources: EU EUDAMED, US FDA

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    STEALTHSTATION SYSTEM THREE DIMENSIONAL C-ARM INTERFACE

    FDA 510(k)
    FDA Class 2 ·Neurology

    nSpire Health

    FDA UDI
    NSPIRE HEALTH, INC.·10852417003672·KoKo Standard Pulmonary Function Filter, White ...

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113669·PS-C Insert, Size 4 x 14mm

    Octane Straight

    FDA UDI
    Choice Spine, LP·10885862236210·

    Octane Straight PC

    FDA UDI
    Choice Spine, LP·10885862277633·

    PRIME ECG SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    PHOTOTHERAPY LAMP 900IW501JE PHOTOTHERAPY POWER MODULE 900IW502JE

    FDA 510(k)
    FDA Class 2 ·General Hospital

    EXp Tibial Insert ; Intended Use of Device(s): The Proven Gen-Flex Total Knee System is intended for: a. Total knee replacement due to osteoarthritis, osteonecrosis, rheumatoid arthritis, and/or post-traumatic degenerative problems; and b. Revision of failed previous reconstructions where sufficient bone stock and soft tissue integrity are present.

    FDA Enforcement
    Class II ·Terminated·Stelkast Co·January 21, 2015

    ONCOZENE MICROSPHERES

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code KRD·July 28, 2022

    EASYPUMP: LT 270-132: 270 ML, 22 ML/HR

    FDA Adverse Event
    Malfunction ·I-FLOW LLC·Product code MEB·November 7, 2014

    EON MINI

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·March 22, 2013

    HOME CHOICEPRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·March 17, 2011

    COBAS 6000 C501 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code CEM·March 26, 2008

    ANGIODYNAMICS / SMART PORT

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code LJT·August 21, 2017

    Oxygen Mask, Model No. 8120-7 Product Usage: Oxygen Mask, High Concentration partial rebreather, with 7 foot (2.1 m) supply tube, Elastic Strap Fixation, Single patient use.

    FDA Enforcement
    Class II ·Terminated·Salter Labs·July 30, 2014

    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

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    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