3 results
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41ms
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Sources: EU EUDAMED, US FDA
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Status: Open, Classified
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GenetiSure Dx Labeling Kit, REF: K1201-64105, contains human reference DNA female aliquot, REF5190-7317. A required kit for the GenetiSure Dx Postnatal assay (K1201A).
FDA Recall
Open, Classified
·Agilent Technologies, Inc.·Product code PFX·March 20, 2025
Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter Model/Catalog Number: TA-06-0001 Product Description: Common Name: Diagnostic intravascular catheter Description: The Novasight Hybrid catheter is a 3Fr single use, sterile device, which will be able to perform transluminal ultrasound and optical coherence tomography imaging of adults. The catheter is capable of real-time 2D side viewing ultrasound and optical imaging acquired simultaneously providing precisely co-registered images with the ability to produce rapidly post processed rendered longitudinal images of the vessel. Packaging: The Novasight Hybrid Catheter is packaged in a packaging system including the protective packaging and the sterile barrier system.
FDA Recall
Open, Classified
·Conavi Medical Inc.·Product code OBJ·March 12, 2025
MAGEC 1 System
FDA Recall
Open, Classified
·NuVasive Specialized Orthopedics, Inc.·Product code PGN·June 25, 2019