BEUDAMED
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    LUMINEX FLEXMAP 3D INSTRUMENT SYSTEM, LUMINEX XPONENT 4.0 SPI SOFTWARE, FLEXMAP 3D IVD CALIBRATION KIT, FLEXMAP 3D IVD P

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SeaSpine

    FDA UDI
    Avalign Technologies, Inc.·00190776149598·STRAIGHT OSTEOTOME, 13mm

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776391317·Straight Osteotome, 13mm

    SPEEDFIX SUTURE IMPLANT, 3.0MM DRILL, PATHFINDER OBTURATOR, SHARP TIPPED OBTRURATOR, LOW PROFILE DRILL GUIDE MODEL OM-75

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COAXIAL INTRODUCER SET

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·September 5, 2024

    NV GXL LINER LIPPED 32MM ID, GROUP 1 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·September 5, 2024

    ALT HA S CLR EXT

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code MEH·November 14, 2023

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·May 20, 2013

    OCUSCAN RXP

    FDA Adverse Event
    Malfunction ·ALCON - IRVINE TECHNOLOGY CENTER·Product code IYO·July 28, 2014

    PFC SIGMA/OV/DOME PAT 3PEG,38

    FDA Adverse Event
    Injury ·DEPUY (IRELAND)·Product code JWH·June 1, 2011

    NV GXL LINER NEUTRAL, 36MM ID, GROUP 2 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·May 31, 2024

    NV GXL LINER NEUTRAL, 32MM ID GROUP 1 CUPS

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·August 12, 2024

    BIOLOX DELTA FEMORAL HEAD 32MM OD, -3.5MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·October 3, 2024

    NV GXL LINER LIPPED 36MM ID GROUP 2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·November 1, 2022

    The Propaq LT Series monitors. Model numbers 802LTAN, 802LT0N, and 802LTRN. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medical-surgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. intended to be used by clinicians and medically qualified personnel for single or multiparameter vital signs monitoring of ambulatory and nonambulatory patients, including neonate, pediatric and adult patients. These devices are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by these devices are hospital general medicalsurgical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services, and other healthcare applications. The monitors can be used as stand-alone devices or as devices networked to an Acuity Central Station through wireless communication over a Welch Allyn FlexNet network.

    FDA Enforcement
    Class II ·Terminated·Welch Allyn Protocol, Inc·January 15, 2014