BEUDAMED
    142 results · 33ms · Sources: EU EUDAMED, US FDA

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    Diaphragmatic/Phrenic Nerve Laparoscopically-Implanted Stimulator

    FDA Pre-Market Approval
    FDA Class 3 ·NeuRX Diaphragm Pacing System (DPS)

    ReLine

    FDA UDI
    Nuvasive, Inc.·00195377047014·RELINE-O Trial, 6mm H Lamina Ang N L-pop

    Paradigm

    FDA UDI
    Proprio, Inc.·00850042604212·Paradigm DRF Ratcheting Clamp

    MicroAire®

    FDA UDI
    Microaire Surgical Instruments LLC·00847399000958·SMALL SAGITTAL SAW BLADE, 10.2mm X 18.3mm X 0.5mm

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00845694005661·Ratcheting Screwdriver

    Drill Bit

    FDA UDI
    Treace Medical Concepts, Inc.·00810111221597·Drill Bit - Short

    WANGENSTEEN TISSUE FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896059405·WANGENSTEEN TISSUE FORCEPS TUNGSTEN CARBIDE SER...

    STRABISMUS BABY SCISSORS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896083479·STRABISMUS BABY SCISSORS STRAIGHT BLADE POWER C...

    SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.

    FDA 510(k)
    FDA Class 2 ·Hematology

    HAD1717MC

    FDA 510(k)
    FDA Class 2 ·Radiology

    Intravascular Radiation Delivery System

    FDA Pre-Market Approval
    FDA Class 3 ·BETA-CATH (TM) SYSTEM

    System, Endovascular Graft, Aortic Aneurysm Treatment

    FDA Pre-Market Approval
    FDA Class 3 ·ZENITH AAA ENDOVASCULAR GRAFT AND H&L-B ONE-SHOT INTRODUCTINO SYSTEM

    ANIMAS INSULIN CARTRIDGE

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·September 13, 2016

    BeneVision N1 Patient Monitor (N1). Part Numbers: 6660E-PA00017, 6660E-PA00014, 6660E-PA00012, 6660E-PA00011, 6660E-PA00018, 6660E-PA00015, 6660E-PA00020, Q6660E-PA00011, 6660E-PA00021, 6660E-PA00016, 6660E-PA00019, Q6660E-PA00018, 6660E-PA00010, Q6660E-PA00010, Q6660E-PA00021, Q6660E-PA00012, 6660E-PA00030, 6660E-PA00041, 6660E-PA00035, 6660E-PA00032, 6660E-PA00031. Software Versions: 1.04.00.01, 01.05.00.01, 01.06.00.01, and 01.06.01.01 The patient monitor is intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.

    FDA Recall
    Open, Classified ·Mindray DS USA, Inc. dba Mindray North America·Product code MHX·August 15, 2025

    Clarius Ultrasound Scanner

    FDA UDI
    Clarius Mobile Health Corp·07540205000328·

    VITROS IMMUNODIAGNOSTICS PRODUCTS ANTI-HCV REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MZO·October 24, 2014

    OT ULTRALINK METER

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

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MEDTRONIC NEUROMODULATION·Product code LKK·July 1, 2013

    DEPTH GAUGE VARIAX DISTAL RADIUS, SCREWS Ø2.3/2.7X40MM, BLACK

    FDA Adverse Event
    Malfunction ·STRYKER GMBH (MDR)·Product code HRS·September 24, 2014

    DEPTH GAUGE VARIAX DISTAL RADIUS, SCREWS Ø2.3/2.7X40MM, BLACK

    FDA Adverse Event
    Malfunction ·STRYKER GMBH (MDR)·Product code HRS·September 24, 2014