BEUDAMED
    83 results · 23ms · Sources: EU EUDAMED, US FDA

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    Automated Breast Ultrasound

    FDA Pre-Market Approval
    FDA Class 3 ·SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface Assembly

    Automated Breast Ultrasound

    FDA Pre-Market Approval
    FDA Class 3 ·SoftVue™ Automated Whole Breast Ultrasound System with Sequr™ Breast Interface

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377047236·RELINE-O Trial, 12mm H TP N L-pop

    Preat

    FDA UDI
    Preat Corporation·00842092167441·BPD (Better Plastic Dovetail)

    OptumSI Implant System

    FDA UDI
    SI Solutions, LLC·00850057247152·Length Gauge

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694010894·Screw Remover

    TAURUS

    FDA UDI
    CTL Medical Corporation·00841732150829·5.5mm Straight Rod 40mm Ti Alloy

    Golden Isles Pedicle Screw System

    FDA UDI
    Intelivation, LLC·G079C2522000400·Straight Titanium Rod

    Taurus Pedicle Screw System

    FDA UDI
    SINTX Technologies, Inc.·M555252200040·Taurus Pedicle Screw System- Straight Rod 5.5x40mm

    Preference 2

    FDA UDI
    SINTX Technologies, Inc.·M555102200040·Straight Rod 6.0mm, 40mm

    Universal Base Conical Connection (CC)

    FDA 510(k)
    FDA Class 2 ·Dental

    REVISION MODULAR STEM Ø20MM

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code LZO·January 18, 2022

    PULSAR GENERATOR, MODEL PS100-100, AND PEAK PLASMABLADE TISSUE DISSECTION DEVICE, MODEL PS200-040

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

    Stent, Coronary

    FDA Pre-Market Approval
    FDA Class 3 ·NIRFLEX PREMOUNTED STENT

    Device, Thermal Ablation, Endometrial

    FDA Pre-Market Approval
    FDA Class 3 ·HYDRO THERMABLATOR ENDOMETRIAL ABLATION SYSTEM

    NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm Pacing System, Patient Kit, SCI 20-0028 NeuRx DPS Surgical Kit, HDE 20-0040 NeuRx Diaphragm Pacing System Spare Sterile Components 21-0001-99 Mapping Probe 21-0004-99 Indifferent Electrode 21-0007-99 Lead Tunneler Set 21-0009-99 Blue Cable Set 21-0010-99 Transducer Tubing 21-0017-99 PermaLoc Electrode 21-0023-99 Green Cable 21-0024-99 Orange Cable 21-0025-99 Yellow Cable 21-0026-99 White Cable 77-0050 Surgeon Instruction Manual 20-0045 NeuRx DPS System Kit, ALS HDE 20-0046 NeuRx Diaphragm Pacing System, Patient Kit, ALS Marketed under HDE H070003 as well as H100006

    FDA Enforcement
    Class III ·Terminated·Synapse Biomedical Inc·July 27, 2022

    Clarius Ultrasound Scanner

    FDA UDI
    Clarius Mobile Health Corp·07540205000991·High-density transducer type – curvilinear arra...

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 10, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OYC·September 17, 2014

    ACCU-CHEK ® INFORM METER

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·July 1, 2013