6 results
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14ms
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Sources: EU EUDAMED, US FDA
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·October 21, 2015
This reagent is for in vitro diagnostic use. Pax-5 (1EW) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human Pax-5 in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated Bond system.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·March 2, 2016
Leica M530 OHX Microscope System Supplied with 100 - 120 Vac.
FDA Enforcement
Class II
·Terminated·Leica Microsystems, Inc.·August 15, 2018
AVS Aria Cage, Catalog Number 48753212 Product Usage: The Stryker Spine AVS¿ ARIA 1M PEEK Spacers are intervertebral body fusion devices indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1 . The AVS¿ ARIA TM PEEK Spacers are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine.
FDA Enforcement
Class II
·Terminated·Stryker Spine·October 17, 2018
Cell Marque, PAX8 (MRQ-50 Mab.), 7 mL, REF PA0808, IVD, This antibody is intended for in vitro diagnostic (IVD) use. PAX-8 (MRQ-50) Mouse Monoclonal Primary Antibody is intended for laboratory use in the detection of the PAX-8 protein in formalin-fixed, paraffin-embedded tissue stained in qualitative immunohistochemistry (IHC) testing
FDA Enforcement
Class II
·Terminated·Leica Biosystems Richmond Inc.·September 20, 2017
PICC Kits with Peel-Away Sheath Component; catheter, intravascular, therapeutic, ultrasound Product Usage: catheter, intravascular, therapeutic, ultrasound
FDA Enforcement
Class II
·Terminated·Arrow International Inc·September 2, 2015