BEUDAMED
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    Z3D CONTRAST ACUITY

    FDA 510(k)
    FDA Class 2 ·Radiology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707000983·MICRO SECT SCREWS U S/STEEL 12mm

    SchureMed

    FDA UDI
    SCHUERCH CORPORATION·00810014605005·BERCHTOLD OPERON D850, D750 3" DELUXE

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450051702·

    QUICK COMBO PAD

    FDA Adverse Event
    Injury ·PHYSIO CONTROL CORP.·Product code MLN·January 17, 1997

    ACCESS MYOGLOBIN ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33310, 33315, 33319, 33316

    FDA 510(k)
    FDA Class 2 ·Immunology

    TOTAL CURE

    FDA 510(k)
    FDA Class 2 ·Dental

    10MM/125 DEG TI CANN TFNA 235MM/LEFT - STERILE

    FDA Adverse Event
    Injury ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HSB·June 28, 2019

    ATLAS II VR

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

    HS III PROXIMAL SEAL SYSTEM 4.3MM

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC.·Product code DXC·April 7, 2011

    ISOMED

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·July 22, 2008

    DPM Central Station Mindray DS USA, Inc. 800 MacArthur Boulevard, Mahwah, NJ 07430 The Central Monitoring Station (CMS) network transfers information between DOM Central Station and other network devices. It also allows information transfer between several CMS. Network connections consist of hardwired network cables and or WLAN connections. The DPM Central Station is used for remote monitor management, storing, printing, reviewing, or processing of information from net worked devices, and it is operated by medical personnel in hospitals or medical institutions.

    FDA Enforcement
    Class II ·Terminated·Mindray DS USA, Inc. d.b.a. Mindray North America·January 9, 2013

    Angiotech Pediatric Bone Marrow Needle. Pediatric Bone Marrow Needle. STERILE. Product Number: ION18015. 510k K980196. MEDICAL DEVICE TECHNOLOGIES, INC. 3600 Southwest 74th Avenue, Gainesville, Florida 32608 U.S.A. Intended Use: Pediatric Bone Marrow Needle

    FDA Recall
    Terminated ·Medical Device Technologies, Inc.·Product code KNW·September 1, 2009

    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