BEUDAMED
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    EPIQ Series Diagnostic Ultrasound System; Affiniti Series Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    APEX Revision Knee

    FDA UDI
    Omni Life Science, Inc.·00841690111696·Modular Stem 17mm x 75mm

    Stainless Steel Archwire

    FDA UDI
    Ortho Arch Company Inc·D90925017719·.016 X .025 UPPER SS RIGHT FORM ARCHWIRES (10)

    COLACTIVE COLLAGEN WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    Low-frequency Multi-function physiotherapy instrument

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·September 8, 2025

    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

    FDA Enforcement
    Class II ·Ongoing·CORIN MEDICAL, LTD.·July 9, 2025

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·November 14, 2014

    UNKNOWN LAG SCREW

    FDA Adverse Event
    Injury ·DEPUY WARSAW·Product code KWA·September 15, 2011

    MIDLINE CATHETERIZATION SET

    FDA Adverse Event
    Malfunction ·ARROW INTERNATIONAL INC·Product code DQY·July 24, 2013

    Siemens brand ACUSON S2000, Model 10434730, ABVS ultrasound systems; Affected sub-components Numbers: (1) 10434968, Boom Welding (for S/Ns 250157, 250162, 250163, 250164, 250166, 250167 and 250169); (2) 10434969, Arm Welding (for S/N's 250171, 250173, 250177); Product is manufactured and distributed by Siemens Medical Solutions USA, Inc., Concord, CA The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging the breast allows volumetric acquisition of the breast image. It provides the operator with the option of using a controlled user independent automated scan motion. The resulting 3D display information enables comprehensive image review by the medical professional. In particular, the coronal plane is scanned, which is not easily accessible with hand-held ultrasound transducers.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc.·Product code IYN·March 28, 2011

    VALIANT CAPTIVIA UNK

    FDA Adverse Event
    Injury ·MEDTRONIC IRELAND·Product code MIH·May 15, 2024

    IVENIX, INFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·FRESENIUS KABI USA LLC·Product code FPA·August 7, 2025

    IVENIX, INFUSION SYSTEM

    FDA Adverse Event
    Malfunction ·FRESENIUS KABI USA LLC·Product code FPA·June 10, 2025

    Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

    FDA Recall
    Open, Classified ·CORIN MEDICAL, LTD. Unit 1-57-8 Corinium Centre Cirencester United Kingdom·Product code JWH·May 23, 2025