BEUDAMED
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    KARL STORZ INSULATED SCISSORS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    EURO-DIAGNOSTIC BLOOD PRESSURE MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADAC MODEL DPS-3300M DIGITAL PROCESSING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORP.·Product code FRN·January 11, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MDTPUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·December 6, 2010

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·July 18, 2014

    CR TIBIAL INSERT SZ4, 9MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·December 18, 2023

    PKG, KELLY FORCEPS, CURVED LEFT, P/N 0250080283. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    BioButton REF BIOST06040 with Software version 3.0.20 The BioButton System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest.

    FDA Enforcement
    Class II ·Ongoing·Biointellisense Inc.·August 21, 2024