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

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    CORIN UNIPOLAR MODULAR HEAD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NUSOFT SPHERICAL, TORIC, ASPHERIC AND BIFOCAL (OCUFILCON B) SOFT CONTACT LENSES FOR DAILY WEAR

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    CAVEX TEMPORARY CEMENT

    FDA 510(k)
    FDA Class 2 ·Dental

    TRIAGE TOX DRUG SCREEN PANEL

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code DIO·March 27, 2017

    TRIAGE TOX DRUG SCREEN PANEL

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code DIO·May 23, 2017

    INTROCAN SAFETY®

    FDA Adverse Event
    Injury ·B. BRAUN MELSUNGEN AG·Product code DQR·August 30, 2016

    TRIAGE TOX DRUG SCREEN PANEL

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code DIO·May 8, 2017

    TRIAGE TOX DRUG SCREEN PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code DIO·October 4, 2019

    NEURO SCREWS,CROSS-PIN,SELF-DRILLING, 1.5X4MM, 5/P

    FDA Adverse Event
    Injury ·STRYKER OSTEOSYNTHESIS FREIBURG·Product code JEY·April 15, 2011

    CENTURY BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·March 28, 2013

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·June 19, 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

    CADD-Solis VIP ambulatory Infusion Pumps, Model 2120 (21-2120, 21-2125, and 21-2127) 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