BEUDAMED
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    AAIO-7, AAIO WIRLESS

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Depth Gauge 60mm

    FDA UDI
    Osteocentric Technologies, Inc.·00816950028175·Depth Gauge 60mm

    restor3d Total Talus Replacement

    FDA UDI
    Restor3d, Inc.·00840097509785·Total Talus, No Suture Hole, 110%

    Kalitec Universal Instruments

    FDA UDI
    Kalitec Direct LLC·B07301K1102250·Tray, Base, 2.25", Universal

    NIDO Pedicle Screw System

    FDA UDI
    Kalitec Direct LLC·B07315K1102000·Tray, 2 inch base

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197539784·Caspar Laminectomy Ronguer 5x10mm 200mm

    YUKON OCT Spinal System

    FDA UDI
    VB Spine LLC·10888857527027·Tap Size Ø5.0 mm

    Vu CPOD™

    FDA UDI
    Seaspine Orthopedics Corporation·10889981051976·Implant Tapered 10x12x5mm (Strut)

    SYNCRO - BLUE TUBE, THE MAGNETICALLY GUIDED ENTERAL FEEDING TUBE- 8FR TUBE

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

    FRONTIER DEVICES NEURO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 10, 2024

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 7, 2025

    EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and therapeutic access to the Upper Gastrointestinal Tract.

    FDA Enforcement
    Class II ·Terminated·Pentax Medical Company·July 30, 2014

    PROGRASP FORCEPS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·November 21, 2012

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·May 13, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 23, 2014

    TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·June 1, 2011

    BD INSULIN PEN NEEDLE

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·November 9, 2015

    Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; 9'', 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A.

    FDA Recall
    Terminated ·Baxter Healthcare Corp. Rt.·Product code FPA·July 6, 2005

    Spectral CT. Computed tomography X-ray system.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 2, 2025