BEUDAMED
    24 results · 21ms · Sources: EU EUDAMED, US FDA

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    DEFENDO Y-OPSY IRRIGATOR

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

    NA

    FDA UDI
    Smith & Nephew, Inc.·03596010033789·BONE SPIKES

    7D Surgical 2mm Drill Bit (Short)

    FDA UDI
    7D Surgical ULC·00628341520744·

    Leva® Anterior Interbody System

    FDA UDI
    Spine Wave, Inc.·10840642109078·Modular Spacer, 38 mm (W) x 30 mm (L) x 19 mm (...

    Navagio

    FDA UDI
    Kalitec Direct LLC·B07330K1100080·Tray Insert

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1100080·Tray Insert

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K1100080·Tray Insert 1, Cosmolock, Arcamed

    TiWAVE L Lumbar Cage System

    FDA UDI
    Kalitec Direct LLC·B07323K1100080·Tray Insert, Level I

    REAL PATIENT AMBULATORY EEG, MODEL EX-AMB-RP (PROPOSED)

    FDA 510(k)
    FDA Class 2 ·Neurology

    EASYRA ALBUMIN, CALCIUM, MAGNESIUM AND INORGANIC PHOSPHOROUS REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RESPIRONICS

    FDA Adverse Event
    Malfunction ·Product code MNT·April 8, 2021

    RADICAL 7

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·December 18, 2014

    RADICAL 7

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·December 18, 2014

    RADICAL-7 COLOR SCREEN HANDHELD

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·May 29, 2015

    RDS3 DOCKING STATION

    FDA Adverse Event
    Malfunction ·MASIMO CORPORATION·Product code DQA·September 17, 2014

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code BTI·May 13, 2013

    PRIMUS

    FDA Adverse Event
    Other ·DRAGER MEDICAL GMBH·Product code BSZ·May 23, 2011

    GE OEC 9600

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS, INC.·Product code JAA·August 14, 2008

    Video Duodenoscope

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·June 8, 2016

    Syringes with exchangeable needles labeled as: SOL-CARE: 1) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 102115SN, UPC 818392019858; 2) SOL-CARE 10ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 102215SN, UPC 818392019865; 3) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 12510SN, UPC 818392018851; 4) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model No. 12558SN, UPC 818392018950; 5) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 27G*1/2 (needle aside), Model No. 12705SN, UPC 818392018967; 6) SOL-CARE 1ml Luer Lock Syringe w/Safety Needle 30G*1/2 (needle aside), Model No. 13005SN, UPC 818392018974; 7) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 (needle aside), Model No. 32110SN, UPC 818392019001; 8) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 21G*1 1/2 (needle aside), Model No. 32115SN, UPC 818392019018; 9) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 (needle aside), Model No. 32210SN, UPC 818392019025; 10) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 22G*1 1/2 (needle aside), Model No. 32215SN, UPC 818392019032; 11) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 23G*1 (needle aside), Model No. 32310SN, UPC 818392019049; 12) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*1 (needle aside), Model No. 32510SN, UPC 818392019063; 13) SOL-CARE 3ml Luer Lock Syringe w/Safety Needle 25G*5/8 (needle aside), Model

    FDA Enforcement
    Class II ·Ongoing·Sol-Millennium Medical Inc.·September 18, 2024