BEUDAMED
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    SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014604442·CMAX 2.25 "SOFTCARE FOAM W/ SOFTCARE COVER

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450178775·

    Disposable Cuff

    FDA UDI
    SUNTECH MEDICAL, INC.·10840935104230·

    XLTEK REAL PATIENT EVOKED POTENTIAL HEADBOX, MODEL EP-16-RP

    FDA 510(k)
    FDA Class 2 ·Neurology

    MARHUKAR TRIPLE LUMEN CATHETER, MODEL 12 FR

    FDA 510(k)
    FDA Class 2 ·General Hospital

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD (SUZHOU)·Product code FOZ·August 11, 2023

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·April 26, 2013

    CVC KIT: 2-LUMEN 12 FR X 6IN (16 CM)

    FDA Adverse Event
    Malfunction ·ARROW INTL., INC.·Product code LFJ·April 7, 2011

    ACCU-VU SIZING CATHETER

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS, INC.·Product code DQO·July 17, 2008

    BACFIX ROD, UNKNOWN

    FDA Adverse Event
    Injury ·ZIMMER BIOMET SPINE INC.·Product code HSB·January 16, 2020

    1.85MM TI MATRIX SCREW SELF-TAPPING/4MM

    FDA Adverse Event
    Malfunction ·SYNTHES (USA)·Product code JEY·January 21, 2015

    2.5 mm Reaming Rod W/Ball Tip 650 mm, Sterile

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·November 30, 2016

    Aurora 4 Series, Aurora 7 lighthead; Models: AUA7 (including TV models). The Aurora Series is intended to illuminate the surgical field and ensure visibility of the surgical site.

    FDA Enforcement
    Class II ·Ongoing·DKK Dai-Ichi Shomei Co., Ltd.·August 21, 2024

    On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors. Product Usage: The On-Board Imager device is an x-ray device used for evaluation of correct patient position in relation to isocenter and verification of treatment fields in relation to anatomical and fiducial landmarks.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems, Inc.·April 30, 2014

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015