BEUDAMED
    13 results · 24ms · Sources: EU EUDAMED, US FDA

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    LimaCorporate Kirschner Wire

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Blade Scalpel

    FDA UDI
    KATENA PRODUCTS, INC.·00841668113523·SLIT BLADE 3.0MM STR (BX/5)

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114056·J-SHAPED CANNULA 25GA ANGLED (PK/10)

    VEO® Lateral Interbody Fusion System

    FDA UDI
    Choice Spine, LP·00840996133371·LATERAL,CONVEX EP SCRAPER,TIP

    SPINEANALYER MODEL SAPOC

    FDA 510(k)
    FDA Class 2 ·Radiology

    CNS-9700 SERIES CENTRAL NURSE STATION AND ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON MEDICAL (SINGAPORE)·Product code FOZ·December 21, 2021

    CLP HIP INSTRUMENTATION

    FDA Adverse Event
    Malfunction ·ENCORE MEDICAL, L.P.·Product code HWB·October 17, 2008

    CAPSUREFIX NOVUS MRI

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code NVN·August 11, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Death ·MEDTRONIC MINIMED·Product code OYC·July 2, 2013

    Spacelabs Healthcare elance Vital Signs Monitor, Model 93300, with Option S. It is a patient monitor with arrhythmia detection or alarms.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare, Llc·November 20, 2013

    Dexcom G4 PLATINUM Receiver with Share Receiver Part Number: MT22495 Receiver (mg/dL), Black; MT22495-PNK, Receiver (mg/dL), Pink; MT22495-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