BEUDAMED
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    KYPHX INFLATABLE BONE TAMP, SIZE 20/3,MODEL K01A, KYPHX INFLATABLE BONE TAMP, SIZE 15/3, MODEL K02A

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    InTess Lumbar Cage

    FDA UDI
    Kalitec Direct LLC·B07312K0102060·Shaver, Open, 6mm

    FOSTER GRANT

    FDA UDI
    FGX INTERNATIONAL INC.·00193033119617·

    Cosmolock

    FDA UDI
    Kalitec Direct LLC·B07311K0100460·ASSEMBLY, CADDIE, CURVED RODS WITH STOPS

    neoWave LS

    FDA UDI
    XENIX MEDICAL LLC·00818345023895·PADDLE SPREADER, 6MM

    NUVOLASE 532 MEDICAL LASER SYSTEM

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

    RADIOCAMERAS EXTRACRANIAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CD HORIZON® SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code MNH·June 10, 2016

    Alteon

    FDA UDI
    Exactech, Inc.·10885862549167·Alteon Cup

    DRILLCHUCK DRILLING SPEED W/KEY F/TRS CL

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HWE·March 19, 2013

    DURAMAX CHRONIC HEMODIALYSIS CATHETER

    FDA Adverse Event
    Malfunction ·ANGIODYNAMICS·Product code MSD·February 11, 2011

    RUSCH SLICK SET ENDOTRACHEAL TUBE 8.0

    FDA Adverse Event
    Other ·RUSCH, TELEFLEX MEDICAL COMPANY·Product code BTR·March 5, 2008

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·H10·Product code KWP·April 4, 2013

    Medfusion Syringe Pump Model: Model 4000-0100-50, Model 4000-0101-249, Model 4000-0101-50, Model 4000-0101-51, Model 4000-0101-78, Model 4000-0105-249, Model 4000-0105-51, Model 4000-0105-78, Model 4000-0106-00, Model 4000-0106-01, Model 4000-0106-231

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·June 29, 2022

    Ellipse Implantable Cardioverter Defibrillators (ICDs), Model No. CD1275, CD1311, CD2275, CD2311, CD1411, CD2411 Ellipse ST Implantable Cardioverter Defibrillators (ICDs), Model No. CD1273, CD1309, CD1409, CD2273, CD2309, CD2409.

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Cardiac Rhythm Management Division·September 10, 2014

    Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 23, 2013