BEUDAMED
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    UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two cloud-based software applications within UNiD Adaptive Spine Intelligence (ASI): the UNiD HUB and the UNiD Spine Analyzer. The UNiD HUB cloud-based software is a healthcare application to receive, transfer, display, store data needed for planning a spine surgery or for post-operative follow-up (patient information, X-ray image and recommendations for planning). The UNiD Spine Analyzer cloud based software is a healthcare application intended for assisting healthcare professionals in viewing and measuring images as well as planning spine surgeries.

    FDA Recall
    Open, Classified ·Product code LLZ·December 3, 2024

    Boston Scientific Encore Advantage Kit, Material Numbers (UPN): 1. H74904527011; 2. H74904527052. (Interventional Cardiology and Peripheral Interventions)

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code MAV·August 5, 2025

    Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) VAD/PICC IV KIT, Model Number DYNDV2200; b) ULTRASOUND PIV KIT, Model Number DYNDV2397; c) VAD ACCESS, Model Number DYNJ24276C; d) FETAL INTERVENTION, Model Number DYNJ66041; e) FETAL INTERVENTION, Model Number DYNJ66041A; f) FETAL INTERVENTION, Model Number DYNJ66041B

    FDA Recall
    Open, Classified ·MEDLINE INDUSTRIES, LP Northfield·Product code MLS·May 18, 2023

    Boston Scientific Encore 26 Inflation Device, Material Numbers (UPN): 1. H74904526011; 2. H74904526052; 3. M0067101140; 4. M001151050; 5. M001151062; 6. M00566670. (Interventional Cardiology, Peripheral Interventions)

    FDA Recall
    Open, Classified ·Boston Scientific Corporation·Product code PTM·August 5, 2025

    Innova IGS 630, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code IZI·March 15, 2019

    Innova IGS 6, Interventional Fluoroscopic X-Ray System used in generating fluoroscopic and rotational images of human anatomy for cardiovascular, vascular and non-vascular, diagnostic and interventional procedures.

    FDA Recall
    Open, Classified ·GE Healthcare, LLC·Product code IZI·March 15, 2019

    Philips AneurysmFlow. Model Number: 001015. AneurysmFlow is a software medical device (Interventional Tool) intended to be used in combination with a Philips interventional X-ray system and 3DRA data.

    FDA Recall
    Open, Classified ·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands·Product code LLZ·March 19, 2026

    OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

    FDA Recall
    Open, Classified ·GE Medical Systems, LLC·Product code OXO·March 21, 2025

    Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. ANGIO DRAPE PACK (ADLUG)642-LF DYNJ47665D ANGIO PACK DYNJ30565D ANGIOGRAPHY PACK-LF DYNJ0854485V ARTERIOGRAM DYNJ28082D DYNJ28082F CARDIAC CATH DYNJ67349 CARDIAC CATH PACK DYNJ57874C CATH I PLUS-LF DYNJSCL100 CATH III PLUS-LF DYNJSCL300 CATH LAB ANGIOGRAPHY PACK DYNJ50779F CATH LAB PACK DYNJ41088B DYNJ48085 CATH LAB TRAY DYNJ37389N DYNJ37389O CATH PACK DYNJ62595A DYNJ69997 EP DRAPE PACK-LF DYNJ47645B HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918A INTERVENTIONAL PACK DYNJ56666C INTERVENTIONAL RAD PACK DYNJ44100L INTERVENTIONAL RADIOLOGY PACK DYNJ43664 INTERVENTIONAL RADIOLOGY PK-LF DYNJ0516014AF OR HYBRID-MRMC DYNJ907758A VMA TRAY DYNJ62376A

    FDA Recall
    Open, Classified ·Product code OES·February 27, 2026

    Mammotrak Interventional Coil 3.0T

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MOS·November 4, 2024

    Mammotrak Interventional Coil 1.5T

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MOS·November 4, 2024

    interventional fluoroscopic x-ray system

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·May 15, 2025

    interventional fluoroscopic x-ray system

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·May 15, 2025

    interventional fluoroscopic x-ray system

    FDA Recall
    Open, Classified ·Siemens Medical Solutions USA, Inc·Product code OWB·May 15, 2025

    Achieva TX Interventional Coil 3.0T

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code MOS·November 4, 2024

    OEC Elite REF Image-Intensified Fluoroscopic X-Ray System, Mobile. The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy, interventional tools/devices, and contrast agents during diagnostic, interventional, and surgical procedures.

    FDA Recall
    Open, Classified ·GE OEC Medical Systems, Inc·Product code OXO·November 21, 2024

    Alphenix INFX-8000F, interventional fluoroscopic x-ray system

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·December 19, 2025

    Alphenix INFX-8000H, interventional fluoroscopic x-ray system

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·December 19, 2025

    Alphenix INFX-8000V, interventional fluoroscopic x-ray system

    FDA Recall
    Open, Classified ·Canon Medical System, USA, INC.·Product code OWB·December 19, 2025

    Ziehm Solo FD. Interventional fluoroscopic x-ray system

    FDA Recall
    Open, Classified ·Orthoscan, Inc.·Product code OWB·August 8, 2024