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

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    AESCULAP MONOMAX ABSORBABLE SUTURE

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

    MONOMAX VIOLET 1(4)150CM HRT48 LOOP(M

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code NWJ·June 4, 2019

    MONOMAX VIOLET 1(4)150CM HRT48 LOOP(M

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code NWJ·June 4, 2019

    Bur PM2-70 80K steel Ø4.0x80 sterile

    FDA UDI
    Bien-Air Surgery SA·17630055513059·

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964060021·Endo Carry-On Procedure Kit

    TISSUE FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896082267·TISSUE FORCEPS

    Monoblock Tibial Trial UC Insert

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215043612·

    SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR ROD, SYNERGY ADJUSTABLE TRANSVERSE CONNECTOR LAMP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NTI TENSION SUPPRESSION SYSTEM

    FDA 510(k)
    FDA Unclassified ·Unknown

    BD VACUTAINER® SST¿ II ADVANCE PLUS BLOOD COLLECTION TUBES

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON AND COMPANY (BD)·Product code JKA·May 16, 2018

    ADULT INSPIRATORY HEATED BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·May 8, 2013

    HEARTMATE II LVASE

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·September 12, 2014

    ETS-FLEX - ENDOSCOPIC

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·May 24, 2011

    MICROCUFF SUBGLOTTIC SUCTIONING ENDOTRACHEAL TUBE, 7.0 MM, ORAL

    FDA Adverse Event
    Malfunction ·AVANOS MEDICAL INC.·Product code BTR·April 16, 2021

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·July 21, 2021

    Spacelabs Healthcare XPREZZON Bedside Monitor, Model 91393. The Spacelabs Healthcare XPREZZON Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLG based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module consist of EGG, respiration, invasive and noninvasive blood pressure, Sp02, temperature and cardiac output.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·March 4, 2015

    GE Centricity PACS-IW versions 3.6.0 through 3.7.3.9 SP1, SP2, SP3 and 3.7.3 SPa10, Model Numbers: a) 2052831-00x b) 2050578-0xx c) 2090228-002 d) 2052782-00x

    FDA Enforcement
    Class II ·Terminated·GE Healthcare, LLC·June 19, 2019

    Model Number U225 VISIONIST CRT-P EL

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025