3 results
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5ms
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Sources: EU EUDAMED, US FDA
"J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
FDA Enforcement
Class II
·Terminated·Angiotech (Manan Medical Products, Inc.)·February 13, 2019
Kelyniam Custom Skull Implant (CSI), Model no. PEEK-IM1002
FDA Enforcement
Class II
·Terminated·Kelyniam Global, Inc.·May 23, 2018
CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra Large is intended to be used to disinfect surfaces.
FDA Enforcement
Class II
·Terminated·Metrex Research, LLC.·March 15, 2017