BEUDAMED
    17 results · 28ms · Sources: EU EUDAMED, US FDA

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    SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS

    FDA 510(k)
    FDA Class 2 ·Dental

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517563606·CoRoent Ant TLIF PEEK, 10x12x30mm 8°

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04064984699427·GENUMEDI SILVER SIZE VIII

    JOBST Bella Strong

    FDA UDI
    BSN MEDICAL, INC.·00035664009526·BELLA STRONG 20-30 MM HG ARMSLEEVE KNIT WELT SI...

    General Instrument

    FDA UDI
    ALPHATEC SPINE, INC.·00840180510162·PTP Holed Disc Shaver, 8mm

    NIAGARA® Lateral Access System

    FDA UDI
    VB Spine LLC·10888857517158·Cranial Caudal Blade, Size 150 mm

    OMNIPULSE HOLMIUM LASER SYSTEM, MODEL 1210; OMNIPULSE MAX HOLMIUM LASER SYSTEM, MODEL 1210-VHP AND 1500-A

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

    KAVO QUATTROCARE

    FDA 510(k)
    FDA Class 1 ·Dental

    GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·February 21, 2018

    ASR UNI FEMORAL IMPL SIZE 39

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·May 9, 2013

    TRILOGY 100

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC.,·Product code CBK·August 27, 2014

    HEARTSTART MRX - EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS HEALTHCARE·Product code MKJ·May 18, 2011

    GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)

    FDA Adverse Event
    Malfunction ·TERUMO MEDICAL CORPORATION·Product code DYB·December 16, 2019

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code ITX·November 10, 2022

    Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062). Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transrectal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

    FDA Enforcement
    Class II ·Ongoing·GE Medical Systems, LLC·December 28, 2022

    Philips Zenition 70, Model Number: 718133

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·November 20, 2024

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021