BEUDAMED
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    URGENT PC STIMULATOR; URGENT PC LEAD SET

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Oticon

    FDA UDI
    Oticon A/S·05707131160133·SAFARI 900, BTE DBL

    Endo Carry-On Procedure Kit

    FDA UDI
    MEDIVATORS INC.·00677964069703·Endo Carry-On Procedure Kit

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450277447·

    ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ANTERIOR CERVICAL PLATE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS SYSTEM

    FDA Adverse Event
    Malfunction ·CAREFUSION SD·Product code FRN·January 27, 2022

    Widex

    FDA UDI
    Widex A/S·05706069721775·Widex UNIQUE U-FS BTE (Tan silk S-220 ) Telecoi...

    Widex

    FDA UDI
    Widex A/S·05706069722475·Widex D-PA BTE (Tan silk S-220 ) RC coil

    Widex

    FDA UDI
    Widex A/S·05706069722093·Widex D-FS BTE (Tan silk S-220 ) Telecoil, RC coil

    Widex

    FDA UDI
    Widex A/S·05706069721249·Widex BEYOND B-F2 (Tan silk S-220 ) Telecoil, R...

    Widex

    FDA UDI
    Widex A/S·05706069720969·Widex UNIQUE U-PA BTE (Tan silk S-220 ) RC coil

    Widex

    FDA UDI
    Widex A/S·05706069726978·Widex EVOKE E-PA (Tan silk S-220 ) RC coil

    NC QUANTUM APEX?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 9, 2013

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·August 7, 2008

    7700

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS GMBH·Product code JAA·May 10, 2011

    DELTAFILL18 10MM X 40CM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code KRD·September 10, 2020

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code LNH·August 28, 2025

    MAGNETOM Skyra (DE). Model Number: 10432915. 510(k) Numbers: K101347, K111242, K123510, K133435, K140253, K141977, K142515, K153343, K173592, K202014, K231560.

    FDA Enforcement
    Class I ·Ongoing·Siemens Medical Solutions USA, Inc·October 8, 2025

    Quadra Assura, Sterile EO, Model #/ Part #: CD3265-40/100042335, 100059846; CD3265-40Q/100042336, 100059847; CD3267-40/100042956, 100043569, 100059961, 100078810; CD3267-40Q/100043132, 100043539, 100059917, 100059956, 100078904; CD3365-40C/100080435, 100080436; CD3365-40Q/100080426, 100080427; CD3367-40/100078813, 100079497, 100096097; CD3367-40C/100078597, 100079174, 100079450, 100079490, 100105524; CD3367-40Q/100078851, 100079212, 100079504, 100096098; CD3367-40QC/100078656, 100079193, 100079498, 100079524, 100105513, 100105514, 100138185, 100138213; CD3385-40C/100080778; CD3385-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018