BEUDAMED
    17 results · 27ms · Sources: EU EUDAMED, US FDA

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    XIA SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ADVANCE®

    FDA UDI
    Microport Orthopedics Inc.·M684K00531151·

    MicroAire®

    FDA UDI
    Microaire Surgical Instruments LLC·00847399005366·SST TAP, 1.5mm Dia., 1.1mm DRILL, 1.5mm SCREW

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180154179·5mm, 33cm -- 15G LAP. IRRIGATION/ASPIRATION NEEDLE

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K0131150·Rocker, Hinged Locking

    ACE VERSANAIL

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACTIS ADJUSTABLE CONSTRICTION LOOP

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    ADAPTER NUT

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS SELZACH·Product code LXH·March 15, 2011

    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

    TAXUS¿ LIBERTÉ¿

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·April 11, 2013

    SYNCHROMED EL

    FDA Adverse Event
    Death ·RICE CREEK MFG·Product code LKK·May 28, 2008

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 13, 2011

    Penumbra Neuron Delivery Catheter 053, 115 cm/12 cm-- MP, manufactured by Penumbra Inc., Alameda, CA Percutaneous Catheter, indicated for the introduction of interventional devices into the peripheral, coronary and neuro vasculature.

    FDA Recall
    Terminated ·Penumbra Inc.·Product code DQY·July 1, 2009

    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

    Cocoon Convective Warming System, Product Code: CWS4000 (110V).

    FDA Enforcement
    Class II ·Terminated·Care Essentials Pty., Ltd.·February 12, 2020

    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