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 00840094415669 Advanced Bionics, LLC	M Carrying Case	2025-08-19
GUDID 00840094456198 Advanced Bionics, LLC	HiRes 90K™ Replacement Magnet	2025-07-31
GUDID 00840094483156 Advanced Bionics, LLC	HiRes™ Ultra CI HiFocus™ MS Electrode	2024-08-26
GUDID 00840094481640 Advanced Bionics, LLC	HiRes™ Ultra CI HiFocus™ SlimJ Electrode	2024-08-26
GUDID 00840094456020 Advanced Bionics, LLC	HiRes™ Ultra 3D CI HiFocus™ SlimJ Electrode	2024-08-19
GUDID 00840094455993 Advanced Bionics, LLC	HiRes™ Ultra 3D CI HiFocus™ MS Electrode	2024-08-19
GUDID 00840094455962 Advanced Bionics, LLC	HiRes™ Ultra CI HiFocus™ MS Electrode	2024-08-19
GUDID 00840094448254 Advanced Bionics, LLC	Auria™ PowerCel™ Slim	2024-07-23
GUDID 00840094448247 Advanced Bionics, LLC	Auria™ PowerCel™ Slim	2024-07-23
GUDID 00840094447547 Advanced Bionics, LLC	Naída™ CI M30 Sound Processor	2024-05-29
GUDID 00840094447530 Advanced Bionics, LLC	Naída™ CI M30 Sound Processor	2024-05-29
GUDID 00840094447523 Advanced Bionics, LLC	Naída™ CI M30 Sound Processor	2024-05-29
GUDID 00840094446571 Advanced Bionics, LLC	Naída™ CI M30 Sound Processor	2024-05-29
GUDID 00840094447516 Advanced Bionics, LLC	Naída™ CI M30 Sound Processor	2024-05-28
GUDID 00840094453418 Advanced Bionics, LLC	3D Headpiece Magnet Kit	2024-05-03
GUDID 00840094453395 Advanced Bionics, LLC	3D Magnet Max	2024-05-03
GUDID 00840094452237 Advanced Bionics, LLC	UHP Magnet	2024-05-03
GUDID 00840094450264 Advanced Bionics, LLC	Auria™ External Magnet	2024-05-03
GUDID 00840094450257 Advanced Bionics, LLC	Auria™ External Magnet	2024-05-03
GUDID 00840094447110 Advanced Bionics, LLC	Slim HP 3D Magnet	2024-05-03
GUDID 00840094447066 Advanced Bionics, LLC	Slim HP 3D Magnet	2024-05-03
GUDID 00840094446748 Advanced Bionics, LLC	Slim HP 3D Magnet	2024-05-03
GUDID 00840094446700 Advanced Bionics, LLC	Slim HP 3D Magnet	2024-05-03
GUDID 00840094446625 Advanced Bionics, LLC	Slim HP Standard Magnet	2024-05-03
GUDID 00840094446601 Advanced Bionics, LLC	Slim HP Standard Magnet	2024-05-03
GUDID 00840094445130 Advanced Bionics, LLC	Slim HP Standard Magnet	2024-05-03
GUDID 00840094485570 Advanced Bionics, LLC	Naida CI PowerCel Charger	2024-04-29
GUDID 00840094433977 Advanced Bionics, LLC	M Battery Charger	2024-04-29
GUDID 00840094491007 Advanced Bionics, LLC	AB Remote	2023-12-11
GUDID 00840094492240 Advanced Bionics, LLC	Target CI	2023-12-08
GUDID 07630016878275 Advanced Bionics, LLC	Target CI	2023-11-03
GUDID 00840094448155 Advanced Bionics, LLC	SoundWave™ Professional Suite Software	2023-11-03
GUDID 00840094448148 Advanced Bionics, LLC	SoundWave™ Professional Suite Software	2023-11-03
GUDID 00840094499997 Advanced Bionics, LLC	M T-Mic	2023-05-18
GUDID 00840094499980 Advanced Bionics, LLC	Slim HP 3D Magnet 6	2023-05-18
GUDID 00840094499973 Advanced Bionics, LLC	Slim HP 3D Magnet 4	2023-05-18
GUDID 00840094499966 Advanced Bionics, LLC	Slim HP 3D Magnet 3	2023-05-18
GUDID 00840094499959 Advanced Bionics, LLC	Slim HP 3D Magnet 2	2023-05-18
GUDID 00840094499942 Advanced Bionics, LLC	Slim HP 3D Magnet 1	2023-05-18
GUDID 00840094499935 Advanced Bionics, LLC	Slim HP Standard Magnet 7	2023-05-18
GUDID 00840094499928 Advanced Bionics, LLC	Slim HP Standard Magnet 6	2023-05-18
GUDID 00840094499911 Advanced Bionics, LLC	Slim HP Standard Magnet 5	2023-05-18
GUDID 00840094499904 Advanced Bionics, LLC	Slim HP Standard Magnet 4	2023-05-18
GUDID 00840094499898 Advanced Bionics, LLC	Slim HP Standard Magnet 3	2023-05-18
GUDID 00840094499881 Advanced Bionics, LLC	Slim HP Standard Magnet 2	2023-05-18
GUDID 00840094499874 Advanced Bionics, LLC	Slim HP Standard Magnet 1	2023-05-18
GUDID 00840094499867 Advanced Bionics, LLC	M T-Mic	2023-05-18
GUDID 00840094499850 Advanced Bionics, LLC	M T-Mic	2023-05-18
GUDID 00840094499836 Advanced Bionics, LLC	Slim HP 3D Magnet 7	2023-05-18
GUDID 00840094493285 Advanced Bionics, LLC	M Zn-Air Battery Pak	2023-05-18
GUDID 00840094426993 Advanced Bionics, LLC	M Zn-Air Battery Pak	2023-05-18
GUDID 00840094426986 Advanced Bionics, LLC	M Zn-Air Battery Pak	2023-05-18
GUDID 00840094426979 Advanced Bionics, LLC	M Zn-Air Battery Pak	2023-05-18
GUDID 00840094426931 Advanced Bionics, LLC	M Zn-Air Battery Pak	2023-05-18
GUDID 00840094414679 Advanced Bionics, LLC	Slim HP Magnet Kit	2023-05-18
GUDID 00840094413276 Advanced Bionics, LLC	M Zn-Air Battery Pak	2023-05-18
GUDID 00840094413214 Advanced Bionics, LLC	M Zn-Air Battery Pak	2023-05-18
GUDID 00840094413207 Advanced Bionics, LLC	M Zn-Air Battery Pak	2023-05-18
GUDID 00840094413177 Advanced Bionics, LLC	M Zn-Air Battery Pak	2023-05-18
GUDID 00840094413160 Advanced Bionics, LLC	M Zn-Air Battery Pak	2023-05-18
GUDID 00840094413153 Advanced Bionics, LLC	M Zn-Air Battery Pak	2023-05-18
GUDID 00840094492615 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492608 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492592 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492585 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492578 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492561 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492554 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492547 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492530 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492523 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492516 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492509 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492493 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492486 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492479 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492462 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492455 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492448 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492431 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492424 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492417 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492400 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492394 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492387 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492370 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492363 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492356 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492349 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492332 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492325 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492318 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492301 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094492295 Advanced Bionics, LLC	M Battery	2023-04-13
GUDID 00840094452343 Advanced Bionics, LLC	Zn-Air Battery Pak	2023-02-14
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]	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