Cochlear Americas Warehouse

FDA Filings

This page includes the latest FDA filings for Cochlear Americas Warehouse. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3014579188
• FEI Number: 3014579188
• Name: Cochlear Americas Warehouse
• Owner & Operator: COCHLEAR AMERICAS
• Contact Address: 10350 Park Meadows Drive ; Lone Tree CO 80124 US
• Official Correspondent:
  • Laura - Blair
  • x-303-2642752-x
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 7101 S. Fulton St. Suite E; Centennial, CO 80112 US
• Establishment Type: Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K191921 | PFO Cochlear Americas Warehouse [COCHLEAR AMERICAS]	Osia 2 System	2019-11-19
PMN K190589 | PFO Cochlear Americas Warehouse [COCHLEAR AMERICAS]	Cochlear OsiaTM System	2019-09-16
PMN K182116 | MAH Cochlear Americas Warehouse [COCHLEAR AMERICAS]	BA310 Abutment, BIA310 Implant/Abutment	2019-04-04
LRJ Cochlear Americas Warehouse [COCHLEAR AMERICAS]	Medical Device Disinfectant	2018-10-29
PMN K100360 | LXB Cochlear Americas Warehouse [COCHLEAR AMERICAS]	Baha BIA300 Implants with Abutments	2010-10-06
PMN K090720 | LXB Cochlear Americas Warehouse [COCHLEAR AMERICAS]	Baha BP100 Sound Processor	2009-12-22
PMN K081606 | LXB Cochlear Americas Warehouse [COCHLEAR AMERICAS]	Baha Intenso Sound Processor	2008-10-23
PMN K042017 | LXB Cochlear Americas Warehouse [COCHLEAR AMERICAS]	Baha Divino Sound Processor	2008-10-23
PMN K002913 | LXB Cochlear Americas Warehouse [COCHLEAR AMERICAS]	BAHA HEADBAND	2008-10-23
MJG Cochlear Americas Warehouse [COCHLEAR AMERICAS]	Disposable Biopsy Punch	2006-09-19
PMN K992872 | LXB Cochlear Americas Warehouse [COCHLEAR AMERICAS]	Baha Cordelle II Sound Processor	2005-08-11
PMN P970051 | MHE Cochlear Americas Warehouse [COCHLEAR AMERICAS]	NUCLEUS 24 COCHLEAR IMPLANT SYSTEM	2005-08-10
PMN P970051 | MCM Cochlear Americas Warehouse [COCHLEAR AMERICAS]	NUCLEUS 24 COCHLEAR IMPLANT SYSTEM	2005-08-10
PMN P890027 | MCM Cochlear Americas Warehouse [COCHLEAR AMERICAS]	N22 COCHLEAR IMPLANT SYS FOR PED	2005-08-10
PMN P840024 | MCM Cochlear Americas Warehouse [COCHLEAR AMERICAS]	N22 COCHLEAR IMPLANT SYS FOR ADULTS	2005-08-10
PMN P000015 | MHE Cochlear Americas Warehouse [COCHLEAR AMERICAS]	Nucleus Auditory Brainstem Implant System	2005-08-10
PMN P000015 | MCM Cochlear Americas Warehouse [COCHLEAR AMERICAS]	Nucleus Auditory Brainstem Implant System	2005-08-10