BEUDAMED
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    Independent Corneal Viewing Chamber (IVC-21)

    FDA 510(k)
    FDA Unclassified ·Unknown

    HOFFMANN 3 MODULAR EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VACUETTE SAFETY BLOOD COLLECTION SET

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TAPERLOC MICROP FMRL 10.0MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code JDI·October 29, 2014

    PREFYX PPS SYSTEM

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·August 15, 2011

    DEPUY ASR XL FEM IMP SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTL., LTD. - 8010379·Product code KXA·July 8, 2013

    Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, interventional, and minimally invasive surgery procedures Models: (1) 722223, (2) 722224, (3) 722225, (4) 722226

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    EMBLEM MRI S-ICD Model A219

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·February 17, 2021

    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

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012