BEUDAMED
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    FDA 510(k)
    FDA Class 2 ·General Hospital

    DIVERGENCE-L™ Anterior/Oblique Lumbar Fusion System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00643169523944·TRIAL 2152410 SMALL 12 DEGREES 10MM

    OsteoMed

    FDA UDI
    OSTEOMED LLC·00842528127544·2.4 X 10mm Cannulated Headless Screw, T7

    1.5 LACTOSORB SYSTEM

    FDA UDI
    BIOMET MICROFIXATION, INC·00841036055431·

    STINGRAY LP

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·March 26, 2025

    ACUSON SEQUOIA ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    MATRYX INTERFERENCE SCREW (5.0-6.5MM)

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STINGRAY? LP

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code DQY·May 29, 2026

    PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

    FDA Adverse Event
    Injury ·PFM MEDICAL CPP·Product code LJT·November 26, 2025

    SERVO-I

    FDA Adverse Event
    Malfunction ·MAQUET CRITICAL CARE AB·Product code CBK·October 3, 2014

    ELECTRODE, PACEMAKER, PERMANENT

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 7, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 28, 2011

    SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·January 16, 2018

    ICP SENSOR

    FDA Adverse Event
    Injury ·Product code GWM·December 2, 2015

    REFOBACIN BC R 1X40 US

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·February 20, 2023

    REFOBACIN BC R 1X40 US

    FDA Adverse Event
    Injury ·BIOMET FRANCE S.A.R.L.·Product code MBB·February 20, 2023

    Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 The Laser Catheters are used in conjunction with the Spectranetics CVX-300 Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.

    FDA Recall
    Terminated ·Spectranetics Corporation·Product code MCW·October 31, 2016

    Turbo Elite Atherectomy Catheter. Models: 410-152, 410-154, 414-151, 414-159, 417-152, 417-156, 420-006, 420-159, 423-001, 423-135-01 The Laser Catheters are used in conjunction with the Spectranetics CVX-300¿ Excimer Laser System and are intended for use in patients with single or multivessel coronary artery disease, either as a stand-alone modality or in conjunction with Percutaneous Transluminal Coronary Balloon Angioplasty (PTCA), and who are acceptable candidates for coronary artery bypass graft (CABG) surgery.

    FDA Enforcement
    Class II ·Terminated·Spectranetics Corporation·December 7, 2016

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024