BEUDAMED
    17 results · 33ms · Sources: EU EUDAMED, US FDA

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    ABARIS

    FDA 510(k)
    FDA Class 2 ·Radiology

    JOBST forMen

    FDA UDI
    BSN MEDICAL, INC.·04042809843873·FOR MEN 30-40 MM HG KNEE HIGH CLOSED TOE LARGE ...

    Humelock II Cemented Reversible Shoulder

    FDA UDI
    FX SOLUTIONS·03701037300268·HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW...

    VIAL SHIELD

    FDA UDI
    BIODEX MEDICAL SYSTEMS, INC.·00718175008478·Shield, Vial, 0.31" lead, Magnetic Cap

    Vial Shield, Lead with Magnetic Cap

    FDA UDI
    Mirion Technologies (capintec), Inc.·00879942070064·Vial Shield, Lead with Magnetic Cap

    HUMELOCK REVERSED SHOULDER

    FDA Adverse Event
    Injury ·FX SOLUTIONS·Product code PHX·June 4, 2019

    HUMELOCK REVERSED SHOULDER

    FDA Adverse Event
    Injury ·FX SOLUTIONS·Product code PHX·June 21, 2019

    HDL-CHOLESTEROL PLUS 2ND GENERATION

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    PERIFIX SAFETY EPIDURAL NEEDLES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    I-STAT CHEM8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·February 15, 2022

    I-STAT CARTRIDGE

    FDA Adverse Event
    Injury ·ABBOTT POINT OF CARE·Product code CHL·August 8, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·April 11, 2013

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM INC.·Product code FNL·March 17, 2011

    CYPHER SIROLIMUS-ELUTING CORONARY STENT

    FDA Adverse Event
    Injury ·CORDIS DE MEXICO·Product code NIQ·May 23, 2008

    i-STAT CHEM 8+ Cartridge, List Number 03P91-25; 510 K053110 Useful for monitoring a variety of conditions. The panel of tests is used in the hospital environment to assess kidney function, electrolyte status, acid/base balance, and blood sugar level. This test panel is also used to assess hypertension and hypokalemia.

    FDA Recall
    Terminated ·Abbott Point Of Care Inc.·Product code JGS·February 15, 2011

    Dexcom G4 PLATINUM Receiver Receiver Part Number: MT20649 Receiver (mg/dL), Black; MT20649-PNK, Receiver (mg/dL), Pink; MT20649-BLU, Receiver (mg/dL), Blue. Intended to detect trends and track glucose patterns in persons with diabetes.

    FDA Enforcement
    Class I ·Terminated·Dexcom Inc·April 20, 2016

    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