66 results
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7ms
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Sources: EU EUDAMED, US FDA
Pilot COVID-19 At-Home Test, Reference Number 9901-NCOV-10G, Catalog Number 99COV200L-EN02, UPC Code: 887473000207 (EAN-13: 08800111707728)
FDA Enforcement
Class I
·Ongoing·SD Biosensor, Inc.·May 31, 2023
STANDARD Q COVID-19 Ag Home Test STANDARD Q COVID-19 Ag Home Test is a rapid chromatographic immunoassay for the qualitative detection of SARS-CoV-2 nucleocapsid antigen present in human nasal sample.
FDA Enforcement
Class I
·Ongoing·SD Biosensor, Inc.·March 23, 2022
InstaTrak with Multiple Dataset Navigation, 892.2050 System, Image Processing System, Model Number IT3500 Plus. Product Usage: Usage: The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MR, or X-ray.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·July 18, 2012
Radiological Image Processing System The system is an aid to locate anatomical structures during open or percutaneous surgical procedures. It is indicated for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CS, MR, or X-ray.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 15, 2012
OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012
OEC 8800 Flexview, 892.1650 Image-intensified fluoroscopic x-ray system Product Usage: The 8800 Flexview is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. Clinical applications may include cholangiography, urologic, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. The system may be used for other imaging applications at the physicians discretion.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012
OEC IT3000; IT2500 (EnTrak); IT2500 Plus (EnTrak Plus); IT3500 (InstaTrak); IT3500 Plus (InstaTrak Plus); ConneCTstat; and ConneCTstat Plus picture archiving and communications systems. The systems are an aid to locate anatomical structures during open or percutaneous surgical procedures. It is intended for use in medical conditions that may benefit from the use of stereotactic surgical technique. The system provides a reference to rigid anatomical structures such as sinus, skull, long bone, or vertebra, which are visible on medical images such as CT, MRI, or X-ray.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·September 5, 2012
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·February 25, 2026
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·February 25, 2026
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity.
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·February 25, 2026
Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare.
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·December 3, 2025
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025
BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170
FDA Enforcement
Class I
·Ongoing·Olympus Corporation of the Americas·October 22, 2025