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

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    Vios Monitoring System(TM) Model 2050; Vios Central Station Monitor/Vios Central Server Software

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Ophthalmic Spatula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668102565·KOCH LENS NUCLEUS SPATULA

    POWDER FREE BLUDE NITRILE PATIENT EXAMINATION GLOVE, NON-STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Surgical Mask-Model Number CW01

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code LWS·November 6, 2014

    GREBSET

    FDA Adverse Event
    Injury ·VASCULAR SOLUTIONS, INC.·Product code DQO·September 2, 2011

    KINETRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code MHY·July 18, 2013

    BD¿ NEXIVA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 10, 2019

    LGN PS HIGH FLEX XLPE SZ 5-6 15MM

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·February 18, 2019

    BD¿ NEXIVAS

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 10, 2019

    BD¿ NEXIVA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·January 10, 2019

    Part Number/Part Description: 30-0033-S 30mm Acutrak¿ Fusion Device 6mm Nose AM-0025-S 25.0mm Acutrak¿ 4/5 Bone Screw AM-0030-S 30.0mm Acutrak¿ 4/5 Bone Screw AM-0035-S 35.0mm Acutrak¿ 4/5 Bone Screw AM-0040-S 40.0mm Acutrak¿ 4/5 Bone Screw AM-0045-S 45.0mm Acutrak¿ 4/5 Bone Screw AM-0050-S 50.0mm Acutrak¿ 4/5 Bone Screw AP-67100-S 100mm Acutrak¿ 6/7 Fixation Screw AP-67105-S 105mm Acutrak¿ 6/7 Fixation Screw AP-67110-S 110mm Acutrak¿ 6/7 Fixation Screw AP-67115-S 115mm Acutrak¿ 6/7 Fixation Screw AP-67120-S 120mm Acutrak¿ 6/7 Fixation Screw AP-6740-S 40mm Acutrak¿ 6/7 Fixation Screw AP-6745-S 45mm Acutrak¿ 6/7 Fixation Screw AP-6750-S 50mm Acutrak¿ 6/7 Fixation Screw AP-6755-S 55mm Acutrak¿ 6/7 Fixation Screw AP-6760-S 60mm Acutrak¿ 6/7 Fixation Screw AP-6765-S 65mm Acutrak¿ 6/7 Fixation Screw AP-6770-S 70mm Acutrak¿ 6/7 Fixation Screw AP-6775-S 75mm Acutrak¿ 6/7 Fixation Screw AP-6780-S 80mm Acutrak¿ 6/7 Fixation Screw AP-6785-S 85mm Acutrak¿ 6/7 Fixation Screw AP-6790-S 90mm Acutrak¿ 6/7 Fixation Screw AP-6795-S 95mm Acutrak¿ 6/7 Fixation Screw ATF-140-S 14.0mm Acutrak¿ Fusion Device ATF-160-S 16.0mm Acutrak¿ Fusion Device ATF-180-S 18.0mm Acutrak¿ Fusion Device ATF-200-S 20.0mm Acutrak¿ Fusion Device ATF-220-S 22.0mm Acutrak¿ Fusion Device ATF-240-S 24.0mm Acutrak¿ Fusion Device ATF-270-S 27.0mm Acutrak¿ Fusion Device ATF-320-S 32.0mm Acutrak¿ Fusion Device ATF-370-S 37.0mm Acutrak¿ Fusion Device ATM-100-S 10.0mm Mini Acutrak¿ Fixation Screw ATM-120-S 12.0mm Mini Acutrak¿ Fixation Screw ATM-140-S 14.0mm Mini Acutrak¿ Fixation Screw ATM-160-S 16.0mm Mini Acutrak¿ Fixation Screw ATM-180-S 18.0mm Mini Acutrak¿ Fixation Screw ATM-200-S 20.0mm Mini Acutrak¿ Fixation Screw ATM-220-S 22.0mm Mini Acutrak¿ Fixation Screw ATM-240-S 24.0mm Mini Acutrak¿ Fixation Screw ATM-260-S 26.0mm Mini Acutrak¿ Fixation Screw

    FDA Enforcement
    Class II ·Ongoing·Acumed LLC·January 4, 2023