FDA-Device2025-01-08Class II
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Angiodynamics, Inc.
Hazard
Potential for procedural delays or interruptions during use of the Auryon Atherectomy System due to the Auryon Atherectomy System not advancing to the Activation (Ready) mode.
Sold states
US Nationwide distribution to the states of AR, AZ, CA, CO, CT, FL, GA, IL, IN, KY, LA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, PA, RI, TN, TX, VA, WA, WI.
Affected count
138 units
Manufactured in
603 Queensbury Ave, Queensbury, NY, United States
Products
AURYON LASER SYSTEM 100-120 VAC. Model Number: EXM001. Product Number: EXM-2001-1100
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0770-2025Don't want to check this manually?
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