15 results
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61ms
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Sources: EU EUDAMED, US FDA
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FDA Recall
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Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only
FDA Recall
Open, Classified
·UIH Technologies LLC·Product code JAK·September 12, 2025
Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958
FDA Recall
Terminated
·Implant Direct Sybron Manufacturing, LLC·Product code NDP·September 6, 2018
FilmArray BCID Panel, RFIT-ASY-0126, 30, Rx Only, CE, IVD, UDI: 00815381020086 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT FA Plus 410852/BACT/ALERT FN Plus 410853/BACT/ALERT PF Plus 259790/BACT/ALERT SN Product Usage: is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
FDA Recall
Terminated
·BioFire Diagnostics, LLC·Product code PEN·January 22, 2020
FilmArray BCID Panel, RFIT-ASY-0127, 6, Rx Only, CE, IVD, UDI: 00815381020093 used with the following BACT/ALERT Blood Culture Bottle Catalog No./Description: 410851/BACT/ALERT FA Plus 410852/BACT/ALERT FN Plus 410853/BACT/ALERT PF Plus 259790/BACT/ALERT SN Product Usage: is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with FilmArray systems.
FDA Recall
Terminated
·BioFire Diagnostics, LLC·Product code PEN·January 22, 2020
GE Discovery NM/CT670; GE Discovery NM 630 Product Usage: a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM/CT 670 system, combining Nuclear Medicine (NM) and Computed Tomography (CT) systems, is intended to produce: NM System: General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality.
FDA Recall
Terminated
·GE Healthcare, LLC·Product code KPS·October 12, 2012
NOCTURNAL ELITE CARE CLINER 6980(STD)/6990(X-LG) products are labeled in part: "***NOCTURNAL ELITE CARE CLINER 6980/6990***Winco***ISO 9001-2008 Certified***An infinite position recliner, independent leg rest and lay-flat all in one chair!***With lay-flat positioning and an independent leg rest, Winco's Nocturnal Elite Care Cliner provides optimal comfort for use in nocturnal dialysis, oncology, acute care and other patient care areas.***HEAT MASSAGE (Optional)***KEY FEATURES***Left side swing-arm for modified entry and ease of cleaning***User-adjustable positioning***Attendant controlled Trendelenburg foot release (on left & right side)***Left side fold down table***Right side Pivot Table***Rear push handle**Lay Flat***Hide-away foot rest***Independent leg rest***LiquiCell for added comfort***1.800.237.3377***5516 SW 1st Lane***Ocala, Florida 334474***www.wincomfg.com***". The Care Cliner is a multi position recliner with a steel frame used primarily in clinics, hospitals and treatment centers for recovery, dialysis, oncology, examination, infusion. Sticker with serial number is labeled in part: "***Manufactured By***Winco***Ocala, FL 34474***www.wincomfg.com*** Model No. ***Serial No.***" Note: Model 6988 is a version of the 6980 without the footplate. We have a single, but high volume customer, that requested the chair without the footplate. We put the model in the system so as to call out a specific Bill of Materials to leave off the footplate. Since it was a unique request, there is not a piece of literature for it.
FDA Recall
Terminated
·Winco Mfg., LLC·Product code INM·February 6, 2012
Neurovascular embolization device. The Optima Coil System is a series specialized coils that are inserted into the vasculature under angiographic visualization to embolize intracranial aneurysms and other vascular anomalies. The system consists of an embolization coil implant comprised of platinum/tungsten, affixed to a delivery pusher to facilitate insertion into the hub of a microcatheter. The system is available in various shapes, lengths and sizes. The devices are to be placed into aneurysms to create blood stasis, reducing flow into the aneurysm and thrombosing the aneurysm. Upon positioning coils into the aneurysm, the coils are thermally detached from the delivery pusher in serial manner until the aneurysm is occluded. There are a total of 208 Optima Coil models. Optima Coil Model Numbers and Product description: OPTI0101CSS10 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101CSS10 Optima Coil 1mm x 1cm Complex-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0101HSS10 Optima Coil 1mm x 1cm Helical-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Optima Coil 1mm x 2cm Complex-10 SuperSoft OPTI0102CSS10 Opti
FDA Recall
Open, Classified
·BALT USA, LLC·Product code HCG·January 3, 2024