BEUDAMED
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    IKAROS

    FDA 510(k)
    FDA Class 2 ·Hematology

    Everest & Jennings

    FDA UDI
    GF HEALTH PRODUCTS, INC.·M36889402401·DURA-GEL SPP-AT

    N/A

    FDA UDI
    Tyber Medical, LLC·M695M9402400·

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955937149·Percutaneous Transluminal Angioplasty Balloon C...

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955939488·Percutaneous Transluminal Angioplasty Balloon C...

    JADE PLUS PTA Balloon Dilatation Catheter / JADE PLUS 18 OTW

    FDA UDI
    OrbusNeich Medical (ShenZhen) Co., Ltd.·06934955938313·Percutaneous Transluminal Angioplasty Balloon C...

    STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230)

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

    ZHAOFENG

    FDA 510(k)
    FDA Class 1 ·General Hospital

    TANDEM T:SLIM INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Injury ·TANDEM DIABETES CARE INC.·Product code LZG·June 19, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·February 2, 2013

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORP·Product code MKJ·December 9, 2010

    Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures.

    FDA Enforcement
    Class II ·Terminated·Capintec Inc·April 1, 2020

    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    PM1214 NUANCE SR RF; PM1230 and PM2230 NUANCE MRI; PM2214 NUANCE DR RF These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017