BEUDAMED
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    VISIONAIRE UK Patient Matched Cutting Guides

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VITA TITANKERAMIK

    FDA UDI
    Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft·J017B2115120·VITA TITANKERAMIK INTENSIVE, IN5, 12 g

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·00636257073414·PROTECT PATELLA TRACKING BRACE, LT, MD

    Millennium

    FDA UDI
    Avalign Technologies, Inc.·00190776199494·SAYEREDDICK KNOT PUSHER CLOSED

    ALEUTIAN® Interbody Systems

    FDA UDI
    VB Spine LLC·10888857308060·Parallel Rasp Size: 18x45x17 mm

    MMODIFICATION TO LAMINARIA

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    BONEBAC T-PLIF INTERVERTEBRAL BODY FUSION DEVICE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ACTIVA

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code MHY·February 10, 2020

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·October 22, 2008

    HEMOPRO2 EXTENSION CABLE

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code GEI·August 5, 2011

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·July 8, 2013

    Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO

    FDA Enforcement
    Class I ·Ongoing·Abbott Vascular·May 25, 2022

    ACUSON S 1000, ACUSON S 2000, or ACUSON S 3000 ultrasound systems with software version C3, C3, C3, or C1. Model numbers: 10041461, 10440017  S 2000 system 10441730  S 3000 system 10441701  S 1000 system Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·August 5, 2015

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025