FDA Device Entity Profile: Auris Health, Inc.

Known Identifiers & Locations

FEI Numbers 3014447948, 3023460764

Owner Operator Numbers 10057462

Locations Covered San Jose, CA, US; Santa Clara, CA, US

Registered Establishments (2)

Registration #	Establishment Name	Location	Establishment Type(s)	Action
3017425975	Auris Health, Inc	Santa Clara, CA, US	Develop Specifications But Do Not Manufacture At This Facility	View Details
3023460764	Auris Health, Inc.	San Jose, CA, US	Repack or Relabel Medical Device,Manufacture Medical Device	View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (1)

Recall #	Product Description	Initiation Date	Status	Action
Z-0025-2020	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120 Reason: Reports of aspirating biopsy needle breakage	2019-04-19	Terminated	View Details

Profile Disclaimer

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