28 results
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7ms
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Sources: EU EUDAMED, US FDA
GEO Instrument Kit for EPS Plate, REF: 70120001, part of the GEO FirstFUSE 1st MTP Joint Arthrodesis Plating System
FDA Enforcement
Class II
·Ongoing·GRAMERCY EXTREMITY ORTHOPEDICS·April 26, 2023
Custom surgical kits and trays: GEO-MED TOTAL KNEE PACK PGYBK, REF 89-6664.04 GEO-MED TOTAL HIP PACK, REF 89-6664.03 surgical kits
FDA Enforcement
Class II
·Terminated·DeRoyal Industries Inc·July 25, 2012
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.2 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to position the patient, x-ray source and digital detector in such a way as to expose only the desired patient anatomy to X-rays and capture the resulting x-ray image. They are then intended to process the acquired image to a diagnostic viewing level and export it in DICOM format through an option of several distribution media including film, paper, CD-DVD and digital PACS archives. The system is intended for routine, daily, dedicated use in radiographic diagnosis. It can be used in any type of specialized radiology wards or for general radiographic diagnostics
FDA Enforcement
Class II
·Terminated·Visaris DOO·May 23, 2018
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.4 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to position the patient, x-ray source and digital detector in such a way as to expose only the desired patient anatomy to X-rays and capture the resulting x-ray image. They are then intended to process the acquired image to a diagnostic viewing level and export it in DICOM format through an option of several distribution media including film, paper, CD-DVD and digital PACS archives. The system is intended for routine, daily, dedicated use in radiographic diagnosis. It can be used in any type of specialized radiology wards or for general radiographic diagnostics
FDA Enforcement
Class II
·Terminated·Visaris DOO·May 23, 2018
Visaris Vision/Auto, ddRAura OTC APS, Diagnostic X-Ray System, Version 2.3 The Vision systems are intended for use in all areas of diagnostic radiography imaging and specifically at secondary and tertiary levels of medical care. Powerful positioning capability makes this system particularly suited for institutions with immobile or hardly mobile patients, such as trauma wards and emergency departments. The system s versatility also makes it suitable for unified diagnostic imaging services for medium size hospitals where this system can cover all diagnostic radiography needs. In general, Vision systems are intended to position the patient, x-ray source and digital detector in such a way as to expose only the desired patient anatomy to X-rays and capture the resulting x-ray image. They are then intended to process the acquired image to a diagnostic viewing level and export it in DICOM format through an option of several distribution media including film, paper, CD-DVD and digital PACS archives. The system is intended for routine, daily, dedicated use in radiographic diagnosis. It can be used in any type of specialized radiology wards or for general radiographic diagnostics
FDA Enforcement
Class II
·Terminated·Visaris DOO·May 23, 2018
GEO-MED CATARACT PACK, REF 89-5790.08
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED BIOPSY TRAY, REF 89-8753.01
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.08
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PODIATRY PACK PGYBK, REF 89-6240.05
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED OPTHALMOLOGY CSTM PCK, REF 89-6387.09
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PODIATRY PACK PGYBK, REF 89-8700.02
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED LOWER EXTERMITY PACK, REF 89-8252.02
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED LOCAL ANESTHESIA PACK, REF 89-10800.01
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED KNEE ARTHROSCOPY PACK, REF 89-5795.07
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED UPPER EXTERMITY PACK, REF 89-8253.02
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PODIATRY PACK PGYBK, REF 89-8700.01
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PLASTIC HAND PACK RF, REF 89-6667.09
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED PLASTIC HAND PACK RF, REF 89-6667.10
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED SHOULDER ARTHROSCOPY KNEE PACK, REF 89-5797.09
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022
GEO-MED TOTAL KNEE PACK A & B, REF 89-6799.02
FDA Enforcement
Class II
·Ongoing·DeRoyal Industries Inc·December 21, 2022