BEUDAMED
    20 results · 22ms · Sources: EU EUDAMED, US FDA

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    IN-TIME RETRIEVAL DEVICE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K0101090·Distractor, Smooth Paddle, Lordotic, 9mm

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01410N0·Cervical Rasp, 15 x 12, 10mm, 0 Degree, No Taper

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0101090·Distractor, Smooth Paddle, 9mm

    InTess C Cervical Cage System

    FDA UDI
    Kalitec Direct LLC·B07309K01410T0·Cervical Rasp, 15 x 12, 10mm, 7 Degree, Tapered

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0142090·Trial, TLIF, 32L OB CRV 7Deg, 9mm

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K0144090·Trial, TLIF, 32L OB STR 7Deg, 9mm

    SLT LASERPRO CTH HOLMIUM LASER SYSTEM

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

    FLUOROPERM 151-OK, PARAGON HDS 100-OK

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE INC.·Product code LZG·February 12, 2015

    ACCU-CHEK ® AVIVA PLUS TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 28, 2014

    OT ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 21, 2013

    TENDRIL ST

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·March 10, 2011

    VNUS CLOSURE FAST CATHETER

    FDA Adverse Event
    Other ·NUS MEDICAL TECHNOLOGIES·Product code GEI·March 12, 2008

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·December 19, 2017

    VACUETTE BLOOD COLLECTION TUBE 3ML K2E K2EDTA

    FDA Adverse Event
    Malfunction ·GREINER BIO-ONE NA INC.·Product code JKA·November 2, 2020

    POLESTAR N30 SURGICAL MRI SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC NAVIGATION, INC. (ISRAEL)·Product code LNH·February 28, 2017

    COOK CELECT FEMORAL VENA CAVA FILTER SET

    FDA Adverse Event
    Injury ·WILLIAM COOK EUROPE·Product code DTK·April 13, 2015

    bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulsed Doppler, Ultrasonic

    FDA Enforcement
    Class II ·Ongoing·B-K Medical A/S·November 12, 2025

    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