BEUDAMED
    17 results · 21ms · Sources: EU EUDAMED, US FDA

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    Filters Regulation: Us FDA ×

    NASOPORE EAR, MODELS ND04, ND05

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    ROUND FILTERS W/INDICATOR

    FDA Adverse Event
    Malfunction ·SPS MEDICAL·Product code FRG·February 28, 2014

    BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD GLUCOSE TEST STRIP SYSTEMS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    BLY-501 ADAPTOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BONE SCREWS, CROSS-PIN, SELF-DRILLING, DIAM.1.2X4MM, UPPERFACE, (5/PACKAGE)

    FDA Adverse Event
    Malfunction ·STRYKER LEIBINGER-FREIBURG·Product code JEY·May 27, 2015

    AFFINITY THREE BIRTHING BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code HDD·March 16, 2013

    AQUAPAK 640 SW, 650 ML W/040 ADAPTOR

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code CAF·March 21, 2011

    ROTATABLE SNARE

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code FDI·September 5, 2014

    BA102

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EGS·March 31, 2016

    BA105

    FDA Adverse Event
    Malfunction ·NAKANISHI INC.·Product code EGS·March 28, 2016

    NSK

    FDA Adverse Event
    Injury ·NAKANISHI INC.·Product code EGS·August 29, 2017

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    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 Ambulatory Infusion Pump, Model 2111 & 2112, Version 1.0, Version 2.0 and Version 3.0 & Model 2120, Version 1.0. Provide measured drug therapy to patients in hospital or outpatient settings.

    FDA Enforcement
    Class II ·Terminated·Smiths Medical ASD, Inc.·June 24, 2015

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022