Aggredyne, Inc.

Medical device manufacturer in Houston, TX.

3510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K181777AggreGuide A-100 ADPJOZ · Traditional 03/29/2019SE
K163274AggreGuide A-100 AA Assay, AggreGuide A-100 InstrumentJOZ · Special 04/05/2017SE
K122162AggreguideJOZ · Traditional 12/20/2013SE

Recalls

RecallProductInitiated
Z-1639-2022 Class IIAggreGuide A-100 InstrumentThe firm identified a software design issue where the improper shut down of the instrument resulted in… 07/23/2019Completed