BEUDAMED
    290 results · 13ms · Sources: EU EUDAMED, US FDA

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    Filters Classification: Class Ii ×

    RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. RadSuite provides a means to distribute, display, and store diagnostic-quality medical images in electronic format.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·September 7, 2016

    Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9, 8.30.8, and 8.31. Advanced Visualization (Image Viewing) includes: Full featured 2D imaging, 3D surface and volume rendering, Real-time Multi-Planar Reformatting (MPR), Real-time oblique imaging, Integrated image fusion, JPEG2000-based Adaptive Bandwidth Streaming, JPEG and Key Image Note export, Presentation States, Annotation and measurement tools, Automated linking, Display protocols, Enterprise Worklist, prior study management, softcopy viewing of digital mammography images provided that only 5 MP monitors with a cleared 510(k) are used and that digitized secondary captures of these images are not viewed for assisting in diagnosis, utilization of thirdparty electronic orthopedic templates, the display of Standard Uptake Value, recording voice reports using third party, plug-in software, and user configurable settings for viewing digital medical images and corresponding data The application provides a means to distribute, display, and store diagnostic-quality medical images in electronic format. The system displays traditional 2D and reconstructed 3D radiological images using Webenabled viewers over both local and wide area networks. The application provides workflow integration capabilities for health care enterprises, wherein: ¿ Radiologists can view, annotate, and tag studies as diagnostically Read. ¿ Referring physicians can view patient images and radiologists annotations. ¿ Tertiary care physicians, medical technologists, and information technology professionals can receive patient records.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·November 30, 2016

    Medline procedural kits labeled as: 1) MEDICAL CIRCUMCISION TRAY, Pack Number CIT6780; 2) NICU CIRCUMCISION TRAY W/OUT CLAMP, Pack Number CIT6920

    FDA Enforcement
    Class II ·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·September 4, 2024

    IC PROFILER-MR - Model 1123. A radiologic quality assurance instrument is a device intended for medical purposes to measure a physical characteristic associated with another radiologic device.

    FDA Enforcement
    Class II ·Terminated·Sun Nuclear Corporation·January 21, 2015

    iConnect Access used with Merge PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·August 24, 2016

    iConnect Access used with Ortho PACS software provides medical specialists with access to diagnostic quality images, reports, and various types of patient data over conventional TCP/IP (e.g., internet) networks.

    FDA Enforcement
    Class II ·Terminated·Merge Healthcare, Inc.·August 24, 2016

    Medical Device Exchange 10MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-010; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder

    FDA Enforcement
    Class II ·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015

    Medical Device Exchange - GelPort Laparoscopic System; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C8XX2N0NCE. EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.

    FDA Enforcement
    Class II ·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015

    Medical Device Exchange Aerosizer Stent Sizing Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 90129-501. EXP (repackager), Merit Medical (OEM) Prosthesis, tracheal, expandable

    FDA Enforcement
    Class II ·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015

    Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CFF03 EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery.

    FDA Enforcement
    Class II ·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015

    Medical Device Exchange 12MM VASCULAR; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 9-AVP2-012; EXP (repackager), Aga Medical (OEM) Transcatheter septal occluder

    FDA Enforcement
    Class II ·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015

    Medical Device Exchange Wire (sternotomy wire); Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 046-072; 046-073; EXP (repackager), A & E Medical (OEM) Suture, nonabsorbable

    FDA Enforcement
    Class II ·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015

    Medical Device Exchange Angio-Seal VIP Platform/Vascular Closure Device 6F; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 610130. EXP (repackager), St. Jude Medical (OEM) Device, hemostasis, vascular

    FDA Enforcement
    Class II ·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015

    Medical Device Exchange Chocolate Balloon Catheter/Over-the-Wire; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CF14-150-25040-OTW. EXP (repackager), TriReme Medical (OEM) Catheter, angioplasty, peripheral, transluminal

    FDA Enforcement
    Class II ·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015

    Medical Device Exchange Insufflation Needle; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number C2201; EXP (repackager), Medline (OEM) Insufflator, laparoscopic

    FDA Enforcement
    Class II ·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015

    Medical Device Exchange -SYSTEM, TACKER SKIN 5MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 6206; EXP (repackager), Covidien (OEM) Implantable Staple

    FDA Enforcement
    Class II ·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015

    Medical Device Exchange SECURESTRAP 5mm Absorbable Strap Fixation Device; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number STRAP25; EXP (repackager), Ethicon (OEM) Strap, implantable.

    FDA Enforcement
    Class II ·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015

    Medical Device Exchange -APPLIER, MULTICLIP ROTATING; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 3299; EXP (repackager), Covidien (OEM) Clip, implantable

    FDA Enforcement
    Class II ·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015

    Medical Device Exchange BAG, SPECIMEN RETRIEVER ENDO; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 2444; EXP (repackager), Covidien (OEM) Specimen retriever bag.

    FDA Enforcement
    Class II ·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015

    Medical Device Exchange - Endo Catch 10mm; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number 173050G; EXP (repackager), Auto Suture (OEM) Endoscope and Accessories

    FDA Enforcement
    Class II ·Terminated·EXP Pharmaceutical Services Corp·August 5, 2015