BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    RADMAX Digital Imaging Software

    FDA 510(k)
    FDA Class 2 ·Radiology

    MUSTMINI OCCIPITAL SCREW

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025

    APTUS 1.5 TRILOCK

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PROUSOUND ALPHA 7 VER. 6.0 DIAGNOSTIC ULTRASOUND SYSTEM MODEL: PROSOUND ALPHA 7 VER. 6.0

    FDA 510(k)
    FDA Class 2 ·Radiology

    DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDI·October 17, 2014

    SUREFLEX 200 LITHOTRIPSY FIBER

    FDA Adverse Event
    Malfunction ·AMS·Product code GEX·June 14, 2013

    TERUMO CDI 540 CALIBRATOR

    FDA Adverse Event
    Malfunction ·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code DRY·July 11, 2011

    MUSTMINI OCCIPITAL SCREW

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025

    MUST MINI OC PRE-BENT TRANSITION ROD 75° Ø3.5/4X 200MM (STE)

    FDA Adverse Event
    Malfunction ·MEDACTA INTERNATIONAL SA·Product code NKG·April 25, 2024

    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000. Product Usage: Usage: The pump is a component of the OAS that provides the pumping mechanism and power to the OAD. The pump does not have an indication independent from that of the systems. The Indications for Use for the peripheral and coronary systems are provided below: Peripheral: The DIAMONDBACK 360¿ and STEALTH Peripheral Orbital Atherectomy Systems are percutaneous orbital atherectomy systems indicated for use as therapy in patients with occlusive atherosclerotic disease in peripheral arteries and who are acceptable candidates for percutaneous transluminal atherectomy. The OAS supports removal of stenotic material from artificial arteriovenous dialysis fistulae (AV shunt). The systems are percutaneous orbital atherectomy systems indicated as therapy in patients with occluded hemodialysis grafts who are acceptable candidates for percutaneous transluminal angioplasty. Coronary: The DIAMONDBACK 360 Coronary Orbital Atherectomy System (OAS) is a percutaneous orbital atherectomy system indicated to facilitate stent delivery in patients with coronary artery disease (CAD) who are acceptable candidates for PTCA or stenting due to de novo, severely calcified coronary artery lesions

    FDA Enforcement
    Class II ·Terminated·Cardiovascular Systems Inc·September 19, 2018

    CSI, Orbital Atherectomy System (OAS) Saline Infusion Pump, Rx only, Part Number: 7-10014, Model Number: SIP-3000.

    FDA Enforcement
    Class II ·Terminated·Cardiovascular Systems Inc·May 31, 2017