BEUDAMED
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    ABREU, MODEL 700

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Bur PM2-70 50K steel Ø2.3x80

    FDA UDI
    Bien-Air Surgery SA·17630055512854·

    DIETHRICH MICRO BULLDOG CLAMP

    FDA UDI
    SONTEC INSTRUMENTS, INC.·B09921008430·DIETHRICH MICRO BULLDOG CLAMP

    6MM BD¿ INSULIN SYRINGE

    FDA Adverse Event
    Malfunction ·BD MEDICAL - DIABETES CARE·Product code FMF·October 12, 2017

    Monoblock Tibial Trial UC Insert

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215043377·

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494463266·Kerrison Punch length 200mm, width 6mm, 90° do...

    COROENT XLR STANDALONE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO JMS APHERESIS NEEDLE

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

    Widex

    FDA UDI
    Widex A/S·05706069773590·Widex EVOKE E-FA (Shocking pink S-220 ) Telecoi...

    DREAMSTATION AUTO CPAP

    FDA Adverse Event
    Malfunction ·RESPIRONICS, INC.·Product code BZD·January 30, 2025

    PRECISION®

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·May 8, 2013

    KARL STORZ

    FDA Adverse Event
    Other ·KARL STORZ GMBH & CO. KG·Product code HRX·May 16, 2008

    8800

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·May 12, 2011

    SYNCHRO2-14 SUPPORT STRAIGHT 215CM

    FDA Adverse Event
    Malfunction ·STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY·Product code DQX·December 14, 2023

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    FDA Adverse Event
    Death ·THORATEC CORPORATION·Product code DSQ·September 24, 2018

    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

    The PrisMax System Version II Hemodialysis Delivery System: Automatic Repositioning System Pump Assembly, specifically tubing, Model Numbers: a) 955626 b) 955558 c) 955701 PrisMax V2 Preventive Maintenance Kit, Product Code SC616 ARPS PUMP, Product Code SC6035 ARPS Pump Assembly, Product Code SC6053

    FDA Enforcement
    Class II ·Terminated·Baxter Healthcare Corporation·March 10, 2021

    Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 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