BEUDAMED
    14 results · 23ms · Sources: EU EUDAMED, US FDA

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    COOL-TIP RF GENERATOR, COOL-TIP RF SYSTEM ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Premier K-FILES

    FDA UDI
    PREMIER DENTAL PRODUCTS COMPANY·D6919053290·FILES PKG 6 31MM 06

    MODIFIED 650 MAMMOGRAPHY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    STERRAD 50 & STERRAD 100S STERILIZERS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ENDOTAK RELIANCE

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

    SPRINT QUATTRO

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·April 13, 2011

    HUT EXT DR FINAL ASSY-STANDARD

    FDA Adverse Event
    Other ·LIEBEL-FLARSHEIM CO.·Product code KQS·May 16, 2008

    COMPREHENSIVE VERSA-DIAL HUMERAL HEAD

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·November 14, 2018

    COMPREHENSIVE MODULAR HYBRID GLENOID BASE

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code KWT·November 14, 2018

    COMPREHENSIVE STANDARD TAPER ADAPTOR

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code MBF·November 14, 2018

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·November 29, 2011

    BACT/ALERT® SA CULTURE BOTTLE

    FDA Adverse Event
    Injury ·BIOMERIEUX INC.·Product code MDB·August 16, 2019

    ACCU-CHEK Tender I 13/80 10 pieces Product Usage: Intended for the infusion and/or injection of fluids into the body below the surface of the skin. The indwelling catheter can be inserted independently from the infusion catheter and can be accessed for the injections through the injection port. The indwelling catheter can also be securely attached to the infusion catheter by means of a proprietary click-lock connector for the infusion of drugs subcutaneously. The infusion set can be detached from the indwelling catheter, and the catheter capped to allow freedom from the infusion set and pump for showers, athletics or other activities.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·January 7, 2015

    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