BEUDAMED
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    MZ Skin LightMAX Supercharged LED Mask 2.0

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

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114100·SIMCOE CORTEX EXTRACTOR 21GA 0.4MM PK/10

    FINN CHAMBERS AQUA

    FDA 510(k)
    FDA Class 1 ·General Hospital

    LOGICSCAN 64 LOGICSCAN 128

    FDA 510(k)
    FDA Class 2 ·Radiology

    I-STAT CG8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·January 5, 2022

    VIDEO MEDIASTINOSCOPE

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

    VIDEO MEDIASTINOSCOPE

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

    VIDEO MEDIASTINOSCOPE

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

    VIDEO MEDIASTINOSCOPE

    FDA Adverse Event
    Injury ·KARL STORZ SE & CO. KG·Product code EWY·December 21, 2021

    ANALYTICAL P MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·October 23, 2008

    ASR UNI FEMORAL IMPL SIZE 45

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL, LTD.·Product code KWA·August 12, 2011

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 9, 2013

    TRUE METRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·July 26, 2024

    18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer  10041227 & 10789400 S1000  10441701 S2000  10041461 S2000 (Refurb) - 10440017 S3000  10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021