BEUDAMED
    17 results · 28ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    MODIFICATION TO:REGISTRADO X-TRA

    FDA 510(k)
    FDA Class 2 ·Dental

    MEDI

    FDA UDI
    MEDI MANUFACTURING, INC.·04051526189805·LEVAMED ACTIVE ANKLE SUP BLACK R V

    ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CADENCE PRECISION INJECTOR, MODEL 103-0304

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPSURE SENSE

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·April 10, 2013

    VITROS IMMUNODIAGNOSTICS PRODUCTS TROPONIN I ES REAGENT PACK

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code MMI·May 14, 2008

    PENUMBRA SYSTEM

    FDA Adverse Event
    Injury ·PENUMBRA, INC.·Product code NRY·April 7, 2011

    BIOLOX HEAD HIP IMPLANT

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·April 25, 2019

    UNKNOWN BIOLOX HEAD

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code LZO·February 13, 2018

    CERASUL, HEAD, M/0, TAPER 12/14

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code JDI·November 4, 2019

    Boston Scientific Innova Over-the-Wire Self-Expanding Stent System, Catalog No. 39181-05153. 5 mm x 150 mm x 130 cm (stent diameter x stent length x delivery system length). Made in USA, Two Scimed Place, Maple Grove, MN 55311 USA. The Innova Self-Expanding Stent System is comprised of two components: the implantable endoprosthesis and the stent delivery system. The stent is a laser cut self-expanding stent composed of a nickel titanium alloy (Nitinol). On both the proximal and distal ends of the stent, radiopaque markers made of tantalum increase visibility of the stent to aid in placement. The stent is constrained within a 6F (2.1 mm maximum OD) delivery system. The delivery system is a triaxial design with an outer shaft to stabilize the stent delivery system, a middle shaft to protect and constrain the stent, and an inner shaft to provide a guidewire lumen. The delivery system is compatible with 0.035 in (0.89 mm) guidewires. When ready to be implanted, the stent is deployed by retracting the middle shaft of the delivery system. A radiopaque marker at the distal end of the delivery system aids in visibility during deployment. As the stent is exposed to body temperature, it expands to appose the vessel wall. The Innova Self-Expanding Stent is available in a variety of diameters and lengths. The delivery system is also offered in two working lengths (75 cm and 130 cm). The Innova Self-Expanding Stent System is indicated for the treatment of peripheral vascular lesions

    FDA Recall
    Terminated ·Boston Scientific Corporation·Product code NIP·May 19, 2011

    Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number: 722012. 4. Allura Xper FD20 Biplane, Model Number: 722013. 5. Allura Xper FD10 OR Table, Model Number: 722022. 6. Allura Xper FD20 OR Table, Model Number: 722023. 7. Allura Xper FD20 Biplane OR Table, Model Number: 722025.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·December 18, 2024

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The Programmer/Recorder/Monitor (PRM) is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    The PRM is intended to be used as part of the ZOOM LATITUDE Programming System to communicate with Boston Scientific implantable pulse generators. The software in use controls all communication functions for the pulse generator.

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 7, 2022

    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Product Usage: Boston Scientific cardiac resynchronization therapy defibrillators (CRT-Ds) are indicated for patients with moderate to severe heart failure who remain symptomatic despite stable, optimal heart failure drug therapy and have left ventricular dysfunction and QRS duration > or equal to 120 ms. This family of pulse generators provide a variety of therapies including: -Ventricular tachyarrhythmia therapy, which is used to treat rhythms associated with sudden cardiac death such as VT and VF; -Cardiac Resynchronization Therapy (CRT), which treats heart failure by resynchronizing ventricular contractions through biventricular electrical stimulation; -Bradycardia pacing, including adaptive rate pacing, to detect and treat bradyarrhythmias and to provide cardiac rate support after defibrillation therapy.

    FDA Enforcement
    Class II ·Terminated·Boston Scientific CRM Corp·October 29, 2014