Advanced Bionics L L C

FDA Filings

This page includes the latest FDA filings for Advanced Bionics L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3009762645
• FEI Number: 3009511234
• Name: Advanced Bionics LLC
• Owner & Operator: Advanced Bionics AG
• Contact Address: Laubisrutistrasse 28 ; Stafa CH-ZH Zurich 8712 CH
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 28515 Westinghouse Pl ; Valencia, CA 91355 US
• Establishment Type: Manufacture Medical Device

• Registration Number: 3006556115
• FEI Number: 3006556115
• Name: Advanced Bionics LLC
• Owner & Operator: Advanced Bionics AG
• Contact Address: Laubisrutistrasse 28 ; Stafa CH-ZH Zurich 8712 CH
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 12740 San Fernando Rd ; Sylmar, CA 91342 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 07630016890093 Advanced Bionics, LLC	UHP Color Cap	2026-03-19
GUDID 07630016890079 Advanced Bionics, LLC	UHP Color Cap	2026-03-19
GUDID 07630016890055 Advanced Bionics, LLC	UHP Color Cap	2026-03-19
GUDID 07630016890031 Advanced Bionics, LLC	UHP Color Cap	2026-03-19
GUDID 07630016890017 Advanced Bionics, LLC	UHP Color Cap	2026-03-19
GUDID 07630016889998 Advanced Bionics, LLC	UHP Color Cap	2026-03-19
GUDID 07630016889967 Advanced Bionics, LLC	UHP Color Cap	2026-03-19
GUDID 07630016886034 Advanced Bionics, LLC	Slim HP Color Cap	2026-03-19
GUDID 07630016866463 Advanced Bionics, LLC	UHP 3D Color Cap	2026-03-19
GUDID 07630016866456 Advanced Bionics, LLC	UHP 3D Color Cap	2026-03-19
GUDID 07630016866449 Advanced Bionics, LLC	UHP 3D Color Cap	2026-03-19
GUDID 07630016866432 Advanced Bionics, LLC	UHP 3D Color Cap	2026-03-19
GUDID 07630016866425 Advanced Bionics, LLC	UHP 3D Color Cap	2026-03-19
GUDID 07630016866418 Advanced Bionics, LLC	UHP 3D Color Cap	2026-03-19
GUDID 07630016866401 Advanced Bionics, LLC	UHP 3D Color Cap	2026-03-19
GUDID 07630016866395 Advanced Bionics, LLC	UHP 3D Color Cap	2026-03-19
GUDID 07630016866388 Advanced Bionics, LLC	UHP 3D Color Cap	2026-03-19
GUDID 00840094451858 Advanced Bionics, LLC	UHP Cable PSP	2026-03-19
GUDID 00840094451841 Advanced Bionics, LLC	UHP Cable PSP	2026-03-19
GUDID 00840094451834 Advanced Bionics, LLC	UHP Cable PSP	2026-03-19
GUDID 00840094451803 Advanced Bionics, LLC	UHP Cable PSP	2026-03-19
GUDID 00840094451773 Advanced Bionics, LLC	UHP Cable BTE	2026-03-19
GUDID 00840094451766 Advanced Bionics, LLC	UHP Cable BTE	2026-03-19
GUDID 00840094451742 Advanced Bionics, LLC	UHP Cable BTE	2026-03-19
GUDID 00840094451735 Advanced Bionics, LLC	UHP Cable BTE	2026-03-19
GUDID 00840094451711 Advanced Bionics, LLC	UHP Cable BTE	2026-03-19
GUDID 00840094451698 Advanced Bionics, LLC	UHP Cable BTE	2026-03-19
GUDID 00840094451667 Advanced Bionics, LLC	UHP Cable BTE	2026-03-19
GUDID 00840094451650 Advanced Bionics, LLC	UHP Cable BTE	2026-03-19
GUDID 00840094451643 Advanced Bionics, LLC	UHP Cable BTE	2026-03-19
GUDID 00840094451636 Advanced Bionics, LLC	UHP Cable BTE	2026-03-19
GUDID 00840094451421 Advanced Bionics, LLC	Neptune Covers	2026-03-19
GUDID 00840094451407 Advanced Bionics, LLC	Neptune™ Covers	2026-03-19
GUDID 00840094451391 Advanced Bionics, LLC	Neptune™ Covers	2026-03-19
GUDID 00840094451384 Advanced Bionics, LLC	Neptune™ Covers	2026-03-19
GUDID 00840094451377 Advanced Bionics, LLC	Neptune™ Covers	2026-03-19
GUDID 00840094451346 Advanced Bionics, LLC	AquaMic™ Color Caps	2026-03-19
GUDID 00840094451322 Advanced Bionics, LLC	AquaMic™ Color Caps	2026-03-19
GUDID 00840094451315 Advanced Bionics, LLC	Neptune™ Cable for AquaMic™	2026-03-19
GUDID 00840094451308 Advanced Bionics, LLC	Neptune™ Cable for AquaMic™	2026-03-19
GUDID 00840094451285 Advanced Bionics, LLC	Neptune™ Cable for AquaMic™	2026-03-19
GUDID 00840094451223 Advanced Bionics, LLC	Neptune™ Cable for AquaMic™	2026-03-19
GUDID 00840094451216 Advanced Bionics, LLC	Neptune™ Cable for AquaMic™	2026-03-19
GUDID 00840094451209 Advanced Bionics, LLC	Neptune™ Cable for AquaMic™	2026-03-19
GUDID 00840094451179 Advanced Bionics, LLC	Neptune Cable for UHP	2026-03-19
GUDID 00840094451131 Advanced Bionics, LLC	Neptune™ Cable for UHP	2026-03-19
GUDID 00840094451117 Advanced Bionics, LLC	Neptune™ Cable for UHP	2026-03-19
GUDID 00840094451087 Advanced Bionics, LLC	Neptune™ Cable for UHP	2026-03-19
GUDID 00840094451063 Advanced Bionics, LLC	Neptune™ Cable for UHP	2026-03-19
GUDID 00840094451049 Advanced Bionics, LLC	Neptune™ Cable for UHP	2026-03-19
GUDID 00840094451025 Advanced Bionics, LLC	Neptune™ Cable for UHP	2026-03-19
GUDID 00840094450998 Advanced Bionics, LLC	Neptune™ Cable for UHP	2026-03-19
GUDID 00840094450974 Advanced Bionics, LLC	Neptune™ Cable for UHP	2026-03-19
GUDID 00840094450967 Advanced Bionics, LLC	Neptune™ Cable for UHP	2026-03-19
GUDID 00840094450905 Advanced Bionics, LLC	Auria™ Huggie	2026-03-19
GUDID 00840094450332 Advanced Bionics, LLC	BTE Cable	2026-03-19
GUDID 00840094450318 Advanced Bionics, LLC	BTE Cable	2026-03-19
GUDID 00840094450301 Advanced Bionics, LLC	BTE Cable	2026-03-19
GUDID 00840094450288 Advanced Bionics, LLC	BTE Cable	2026-03-19
GUDID 00840094450219 Advanced Bionics, LLC	Headpiece Cable Right Angle	2026-03-19
GUDID 00840094450189 Advanced Bionics, LLC	Headpiece Cable Right Angle	2026-03-19
GUDID 00840094450172 Advanced Bionics, LLC	Headpiece Cable Right Angle	2026-03-19
GUDID 00840094450165 Advanced Bionics, LLC	Headpiece Cable Right Angle	2026-03-19
GUDID 00840094450158 Advanced Bionics, LLC	Headpiece Cable Right Angle	2026-03-19
GUDID 00840094450141 Advanced Bionics, LLC	Headpiece Cable Right Angle	2026-03-19
GUDID 00840094450127 Advanced Bionics, LLC	Headpiece Cable Right Angle	2026-03-19
GUDID 00840094450059 Advanced Bionics, LLC	UHP 3D	2026-03-19
GUDID 00840094450035 Advanced Bionics, LLC	UHP 3D	2026-03-19
GUDID 00840094449978 Advanced Bionics, LLC	Concave UHP	2026-03-19
GUDID 00840094449961 Advanced Bionics, LLC	Universal Headpiece UHP	2026-03-19
GUDID 00840094448995 Advanced Bionics, LLC	AAA PowerPak Accessory	2026-03-19
GUDID 00840094447660 Advanced Bionics, LLC	M Zn-Air Battery Pak	2026-03-19
GUDID 00840094447646 Advanced Bionics, LLC	M Zn-Air Battery Pak	2026-03-19
GUDID 00840094447639 Advanced Bionics, LLC	M Zn-Air Battery Pak	2026-03-19
GUDID 00840094447622 Advanced Bionics, LLC	M Zn-Air Battery Pak	2026-03-19
GUDID 00840094447608 Advanced Bionics, LLC	M Zn-Air Battery Pak	2026-03-19
GUDID 00840094447592 Advanced Bionics, LLC	M Zn-Air Battery Pak	2026-03-19
GUDID 00840094447585 Advanced Bionics, LLC	M Zn-Air Battery Pak	2026-03-19
GUDID 00840094447561 Advanced Bionics, LLC	M Zn-Air Battery Pak	2026-03-19
GUDID 00840094446564 Advanced Bionics, LLC	Slim HP Standard	2026-03-19
GUDID 00840094446526 Advanced Bionics, LLC	Slim HP AquaMic™	2026-03-19
GUDID 00840094446427 Advanced Bionics, LLC	Slim HP AquaMic™	2026-03-19
GUDID 00840094446342 Advanced Bionics, LLC	Slim HP AquaMic™	2026-03-19
GUDID 00840094446328 Advanced Bionics, LLC	Slim HP AquaMic™	2026-03-19
GUDID 00840094446304 Advanced Bionics, LLC	Slim HP AquaMic™	2026-03-19
GUDID 00840094446281 Advanced Bionics, LLC	Slim HP AquaMic™	2026-03-19
GUDID 00840094446229 Advanced Bionics, LLC	Slim HP AquaMic™	2026-03-19
GUDID 00840094446144 Advanced Bionics, LLC	Slim HP	2026-03-19
GUDID 00840094446120 Advanced Bionics, LLC	Slim HP	2026-03-19
GUDID 00840094446106 Advanced Bionics, LLC	Slim HP	2026-03-19
GUDID 00840094446069 Advanced Bionics, LLC	Slim HP	2026-03-19
GUDID 00840094446021 Advanced Bionics, LLC	Slim HP	2026-03-19
GUDID 00840094407626 Advanced Bionics, LLC	HiRes™ Ultra 3D Temporary Non-Magnetic Plug	2026-03-19
GUDID 00840094406766 Advanced Bionics, LLC	HiFocus MS Electrode Insertion Tool	2026-03-19
GUDID 00840094406742 Advanced Bionics, LLC	HiRes™ Ultra Mock Up	2026-03-19
GUDID 00840094404960 Advanced Bionics, LLC	RF Cable	2026-03-19
GUDID 00840094404793 Advanced Bionics, LLC	RF Cable	2026-03-19
GUDID 00840094404786 Advanced Bionics, LLC	RF Cable	2026-03-19
GUDID 00840094404762 Advanced Bionics, LLC	RF Cable	2026-03-19
GUDID 00840094404724 Advanced Bionics, LLC	RF Cable	2026-03-19
PMN P960058 | MCM Advanced Bionics LLC [Advanced Bionics AG]	HIRESOLUTION BIONIC EAR SYSTEM	2007-12-14
PMN P960058 | MCM Advanced Bionics LLC [Advanced Bionics AG]	HIRESOLUTION BIONIC EAR SYSTEM	2007-12-14
PMN P960058 | MCM Advanced Bionics LLC [Advanced Bionics AG]	CLARION CII BIONIC EAR	2007-12-14
PMN P960058 | MCM Advanced Bionics LLC [Advanced Bionics AG]	CLARION CII BIONIC EAR	2007-12-14

Similar & Related FDA Registered Companies

• ADVANCED BIONICS28515 Westinghouse Placevalencia, CA 91355 PMA NumberP960058 Supplement NumberS156 Date Received08/12/2022 Decision Date09/09/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
• ADVANCED BIONICS28515 Westinghouse Placevalencia, CA 91355 PMA NumberP960058 Supplement NumberS155 Date Received07/13/2022 Decision Date08/11/2022 Product Code MCM  Advisory Committee Ear Nose & Throat Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No

Related Finance Registrations

NCAGE Code	4YZU8	ADVANCED BIONICS, LLC
CAGE Code	4YZU8	ADVANCED BIONICS, LLC
S.A.M. Registration	4YZU8 [803906382]	ADVANCED BIONICS, LLC
S.A.M. Registration	4YZU8 [803906382]	ADVANCED BIONICS, LLC

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020091027850	Stadersand,Federal Republic of Germany -> Los Angeles, California	ETUI WITH HEATING SYSTEM FOR DRYING OF HEARING SYSTEMS HS CODE SCAC SSLL AMS-REF. LAX233340	3 PA
202005054837	Stadersand,Federal Republic of Germany -> Los Angeles, California	ELECTRICAL DRYING STATION USB HS-CODE 85167970 SCAC SSLL AMS REF. LAX232280	5 PKG
202004297033	Stadersand,Federal Republic of Germany -> Los Angeles, California	ELECTRICAL DRYING STATION USB HS-CODE 85167970 SCAC SSLL AMS REF. LAX232280	5 PKG
2020042315463	Stadersand,Federal Republic of Germany -> Los Angeles, California	ELECTRICAL DRYING STATION USB HS-CODE 85167970 SCAC SSLL AMS REF. LAX232280	5 PKG