BEUDAMED
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    REVERSE SHOULDER PROSTHESIS MONOBLOCK STEM, REVERSE SHOULDER PROSTHESIS HUMERAL INSERTS, MODEL 510-00-006/012

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KNIFE HANDLE

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896049635·KNIFE HANDLE ROUND GOLF BALL GRIP #3

    N/A

    FDA UDI
    Doppkon GmbH & Co. KG·04262494464096·UBE Dilator Size 1 OD 4.8mm, WL 195mm

    CareLiving MM1100 Blood Glucose Test Strips 50ct

    FDA UDI
    Care Living Diagnostics Inc.·00383568100741·Blood Glucose Test Strips,2 bottles of 25 strip...

    EMS JUMPER II DUAL CHANNEL NEUROMUSCULAR STIMULATOR SYSTEM, MODEL E-188

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA

    FDA 510(k)
    FDA Class 2 ·Radiology

    PERCLOSE PROSTYLE SUTURE-MEDIATED CLOSURE AND REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code MGB·February 13, 2023

    PERCLOSE PROGLIDE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·October 28, 2024

    PERCLOSE PROGLIDE¿

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR INC.·Product code MGB·September 5, 2024

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR·Product code NIQ·March 16, 2020

    ACCU-CHEK ® MULTICLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code FMK·May 8, 2013

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·September 12, 2014

    6800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·May 12, 2011

    Brilliance iCT - Model no. 728306 Computed Tomography X-Ray system Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·April 25, 2018

    Syngo.via picture archiving and communication system Syngo via is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    Syngo.x picture archiving and communication system Syngo.x is a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 28, 2016

    Brilliance iCT - Model 728306 Computed Tomography X-ray systems

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·January 31, 2018

    IVEA Product Part Number 16100 Model 500A

    FDA Enforcement
    Class II ·Terminated·Firefly Medical, Inc.·October 11, 2017

    CME America T-Syringe Pump - T34 - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous, intra-arterial, epidural, in close proximity to nerves, and into an intra-operative site (soft tissue/body cavity/surgical wound site).

    FDA Enforcement
    Class II ·Terminated·CME America, LLC·December 9, 2020

    Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·July 14, 2021