BEUDAMED
    17 results · 31ms · Sources: EU EUDAMED, US FDA

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    LNOP BLUE OXIMETRY SENSOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RD SET NEO CS-3

    FDA Adverse Event
    Malfunction ·MASIMO - 52 DISCOVERY·Product code DQA·January 29, 2021

    N/A

    FDA UDI
    GEORGE TIEMANN & CO.·B58210514390·INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

    MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORTHOCEPH OC100 D

    FDA 510(k)
    FDA Class 2 ·Dental

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·July 13, 2017

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·July 13, 2017

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code KWP·January 7, 2016

    I-STAT TROPONIN (CTNI) CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code MMI·February 14, 2012

    PRECISION XCEED PRO

    FDA Adverse Event
    Malfunction ·Product code NBW·April 10, 2013

    GUIDANT 4.5 MM HEARTSTRING PROXIMAL SEAL

    FDA Adverse Event
    Malfunction ·GUIDANT CARDIAC SURGERY·Product code DXC·May 21, 2008

    RENAISSANCE 29

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·April 4, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·February 2, 2021

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·WARSAW ORTHOPEDICS·Product code KWP·February 11, 2021

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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

    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