5 results
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12ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Applied Medical's Inzii 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.
FDA Recall
Terminated
·Applied Medical Resources Corp 22872 Avenida Empresa # 3 Rancho Santa·Product code GCJ·October 21, 2013
Applied Medical's Inzii¿ 12/15mm Retrieval System. Applieds Inzii Tissue Retrieval Bag, Model Number CD004, is classified as a Class II device. It was cleared to market via 510(k) filing K060051. The retrieval bag is a disposable specimen retrieval bag intended for use as receptacle for the collection of tissue, organs, and calculi during laparoscopic procedures. Applieds CD004 has a shelf life of three years. It is provided sterile and packaged in a heat sealed Tyvek pouch.
FDA Enforcement
Class II
·Terminated·Applied Medical Resources Corp·November 20, 2013
Brilliance 16-Slice (Air) Computed Tomography X-ray systems. Intended to produce cross-sectional images of the body.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·November 4, 2015
Brilliance CT 16 Slice Air (Uninterruptible Power Supply (UPS) accessory devices) Computed Tomography X-ray systems and Diagnostic Imaging systems.
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·June 17, 2015
Brilliance 16 Slice (Air), Model 728246 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may include signal analysts and display equipment, patient and equipment supports, components, and accessories
FDA Enforcement
Class II
·Terminated·Philips Medical Systems (Cleveland) Inc·December 12, 2018