BEUDAMED
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    I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)

    FDA 510(k)
    FDA Class 2 ·Radiology

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517564092·CoRoent Ant TLIF PEEK, 11x11x34mm 4°

    Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089404018·

    Summa Orthopaedics System Surgical Instrument

    FDA UDI
    Jeil Medical Corporation·08800089449774·

    G+ SYSTEM

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    INFANT PLETHYSMOGRAPH, MODEL 004400; PEDIATRIC PLETHYSMOGRAPH, MODEL 004400

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    WAVEWRITER ALPHA?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 15, 2025

    PAGEWRITER TC 20 CARDIOGRAPH

    FDA Adverse Event
    Malfunction ·PHILIPS GOLDWAY (SHENZHEN) INDUSTRIAL INC·Product code DPS·May 17, 2021

    TURBO-JECT® SINGLE LUMEN POWER-INJECTABLE PICC

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·January 18, 2017

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·May 14, 2013

    BATT-HANDPIECE MOD F/TRS

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code GEY·September 23, 2014

    LTV

    FDA Adverse Event
    Malfunction ·CAREFUSION 203, INC.·Product code CBK·May 18, 2011

    TURBO-JECT POWER INJECTABLE

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·July 3, 2018

    TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC

    FDA Adverse Event
    Malfunction ·COOK INC·Product code LJS·August 24, 2017

    1820334-2020-01805

    FDA Adverse Event
    Malfunction ·COOK INC·Product code FOZ·October 5, 2020

    TURBO-JECT STANDARD POWER INJECTABLE PICC LINE PICC

    FDA Adverse Event
    Injury ·COOK INC·Product code LJS·June 28, 2018

    SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning. This CT system can be used for low dose lung cancer screening in high risk populations. High risk populations are as defined by professional medical societies.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 10, 2019

    cobas 8000 analyzer series Operators Manual Roche cobas Filter label: Filter (N) Mat. No 03149773001, Contents 1, 768-320 Filter (N) Product Usage: Fully automated immunoassay analyzer intended for the in-vitro quantitative/qualitative determination of analytes in body fluids.

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Operations, Inc.·June 25, 2014

    INLIVEN CRT-P, Model Numbers: a) V284 b) V285 c) W274 d) W275 (added 7/15/2021)

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

    ACCOLADE DR EL MRI (Model L331)

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