BEUDAMED
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    HEM-O-LOK LIGATING CLIP

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

    CRYO.S

    FDA UDI
    Greiner Bio - One GmbH·14039943000535·

    Oticon

    FDA UDI
    Oticon A/S·05707131260475·RIA PRO, RITE 312 WL CBE

    Novo Surgical Inc.

    FDA UDI
    NOVO SURGICAL, INC.·00842331186745·iris scissors, angled on side, 4 1/2" (11.4 cm)

    General Instruments

    FDA UDI
    ALPHATEC SPINE, INC.·00840180519271·Bone Funnel, Flat Tip

    INTERVERTEBRAL FUSION DEVICE WITH BONE GRAFT, LUMBAR

    FDA Adverse Event
    Injury ·MSD DEGGENDORF MFG·Product code OVD·December 18, 2019

    CLYDESDALE PTC SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MSD DEGGENDORF MFG·Product code MAX·October 17, 2019

    PREASSEMBLED SURGICAL WASH SET

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ADVANTAGE PADDLE

    FDA 510(k)
    FDA Class 2 ·Radiology

    ZELTIQ COOLCORE (6.3)

    FDA Adverse Event
    Injury ·ZELTIQ AESTHETICS INC.·Product code OOK·June 19, 2014

    FEMORAL COMPONENT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDH·October 1, 2014

    ACCESS

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - SINGAPORE·Product code FPA·May 29, 2013

    3.5MM 90-S SERFAS ENERGY SUCTION PROBE

    FDA Adverse Event
    Malfunction ·STRYKER ENDOSCOPY PUERTO RICO·Product code GEI·May 9, 2011

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code NKB·April 19, 2019

    Allura Xper FD10C; Model Number: 722001; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper CV20; Model Numbers: 722031; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/20; Model Numbers: 722038; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/15; Model Numbers: 722058; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura CV20; Product Code: 722031; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025

    Allura Xper FD20/10; Model Numbers: 722029; Associated 510(k)s: K102005, K130638, K130842, K133292, K141979, K162859, K161563;

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code OWB·September 3, 2025