Siemens Ag

FDA Filings

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

Siemens Ag holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

Rene van de Zande

FDA Owner/Operator Registration

FDA Filings

Device Company	Device	Date
PMN K150843 Siemens AG	Syngo®.via (version VB10A)	2015-04-24

Similar & Related FDA Registered Companies

SIEMENS HEALTHCARE DIAGNOSTICS INC
Siemens AG/Siemens Healthcare GmbH
Siemens Healthcare Diagnostics Products GmbH
Siemens Healthcare Diagnostics Products Ltd.
Siemens Healthcare Diagnostic Products Gmbh
SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH
SIEMENS HEALTHCARE DIAGNOSTICS
SIEMENS AG MEDICAL SOLUTIONS
Siemens Healthcare Diagnostics, Inc.511 Benedict Avenuetarrytown, NY 10591 PMA NumberP210019 Supplement NumberS001 Date Received08/01/2022 Decision Date12/20/2022 Product Code LOM Advisory Committee Microbiology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No
Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010051 Supplement NumberS017 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010050 Supplement NumberS021 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS HEALTHCARE DIAGNOSTICS INC.glyn Rhonwy, Llanberisgwynedd Ll55 4el LL554 PMA NumberP930027 Supplement NumberS028 Date Received09/15/2022 Decision Date10/14/2022 Product Code MTF Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010053 Supplement NumberS016 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS HEALTHCARE DIAGNOSTICS INC.511 Benedict Ave.tarrytown, NY 10591 PMA NumberP010007 Supplement NumberS017 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOK Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010052 Supplement NumberS016 Date Received09/15/2022 Decision Date10/14/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITEDglyn Rhonwy. Llanberiscaernarfongwynedd, Ll55 4EL PMA NumberP060005 Supplement NumberS016 Date Received09/15/2022 Decision Date10/14/2022 Product Code MTG Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS HEALTHCARE DIAGNOSTICS INC.333 Coney Streeteast Walpole, MA 02032 PMA NumberP930036 Supplement NumberS020 Date Received09/01/2022 Decision Date09/30/2022 Product Code LOK Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Siemens Healthcare Diagnostics, Inc.511 Benedict Avenuetarrytown, NY 10591 PMA NumberP210019 Date Received05/11/2021 Decision Date07/27/2022 Product Code LOM Advisory Committee Microbiology Expedited Review Granted? No
Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010053 Supplement NumberS014 Date Received02/28/2022 Decision Date03/29/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS HEALTHCARE DIAGNOSTICS511 Benedict Avenuetarrytown, NY 10591 PMA NumberP090024 Supplement NumberS011 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS HEALTHCARE DIAGNOSTICS333 Coney Streetwalpole, MA 02032-1516 PMA NumberP990055 Supplement NumberS024 Date Received03/22/2022 Decision Date03/29/2022 Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS HEALTHCARE DIAGNOSTICS333 Coney Streetwalpole, MA 02032-1516 PMA NumberP950021 Supplement NumberS025 Date Received03/22/2022 Decision Date03/29/2022 Product Code MTG Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS HEALTHCARE DIAGNOSTICS333 Coney Streetwalpole, MA 02032-1516 PMA NumberP040004 Supplement NumberS021 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS HEALTHCARE DIAGNOSTICS333 Coney Streetwalpole, MA 02032-1516 PMA NumberP030040 Supplement NumberS021 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Siemens Healthcare Diagnostics, Inc.511 Benedict Avenuetarrytown, NY 10591-5097 PMA NumberP200017 Supplement NumberS002 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS CORP.511 Benedict Avenuetarrytown, NY 10591 PMA NumberP110041 Supplement NumberS013 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS HEALTHCARE DIAGNOSTICS INC.333 Coney Streeteast Walpole, MA 02032 PMA NumberP930036 Supplement NumberS019 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOK Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITEDglyn Rhonwy. Llanberiscaernarfongwynedd, Ll55 4EL PMA NumberP060005 Supplement NumberS014 Date Received02/28/2022 Decision Date03/29/2022 Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS HEALTHCARE DIAGNOSTICS INC.511 Benedict Ave.tarrytown, NY 10591 PMA NumberP010007 Supplement NumberS015 Date Received02/28/2022 Decision Date03/29/2022 Product Code LOK Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS HEALTHCARE DIAGNOSTICS INC.511 Benedict Ave.tarrytown, NY 10591 PMA NumberP100039 Supplement NumberS015 Date Received03/22/2022 Decision Date03/29/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS HEALTHCARE DIAGNOSTICS INC.glyn Rhonwy, Llanberisgwynedd Ll55 4el LL554 PMA NumberP930027 Supplement NumberS026 Date Received02/28/2022 Decision Date03/29/2022 Product Code MTF Advisory Committee Immunology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Siemens Healthcare Diagnostics Products, LTDglyn Rhonwyllanberis, Caernarfon LL55 PMA NumberP010051 Supplement NumberS015 Date Received02/28/2022 Decision Date03/29/2022 Product Code LOM Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS LIMITED
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS
Siemens Shenzhen Magnetic Resonance Ltd.

Related Finance Registrations

NCAGE Code	00P62	SIEMENS AG
NCAGE Code	0CUN0	SIEMENS AG
NCAGE Code	0DLH8	SIEMENS AG
NCAGE Code	0G8C0	SIEMENS AG
NCAGE Code	0GPU8	SIEMENS AG
NCAGE Code	0HYB3	SIEMENS AG
NCAGE Code	1FGQ8	SIEMENS AG
NCAGE Code	DK654	SIEMENS AG
NCAGE Code	DK374	SIEMENS AG
NCAGE Code	D9698	SIEMENS AG
NCAGE Code	D9565	SIEMENS AG
NCAGE Code	D8010	SIEMENS AG
NCAGE Code	D2739	SIEMENS AG
NCAGE Code	D2669	SIEMENS AG
NCAGE Code	D1173	SIEMENS AG
NCAGE Code	D1176	SIEMENS AG
NCAGE Code	D1178	SIEMENS AG
NCAGE Code	D1179	SIEMENS AG
NCAGE Code	D1181	SIEMENS AG
NCAGE Code	D0968	SIEMENS AG
NCAGE Code	D0935	SIEMENS AG
NCAGE Code	D0879	SIEMENS AG
NCAGE Code	D0279	SIEMENS AG
NCAGE Code	D0196	SIEMENS AG
NCAGE Code	CH760	SIEMENS AG
NCAGE Code	C3287	SIEMENS AG
CAGE Code	00P62	SIEMENS AG
CAGE Code	0CUN0	SIEMENS AG
CAGE Code	0DLH8	SIEMENS AG
CAGE Code	0G8C0	SIEMENS AG
CAGE Code	0GPU8	SIEMENS AG
CAGE Code	0HYB3	SIEMENS AG
CAGE Code	1FGQ8	SIEMENS AG
CAGE Code	D9565	SIEMENS AG
CAGE Code	C3287	SIEMENS AG
CAGE Code	D0196	SIEMENS AG
CAGE Code	D0879	SIEMENS AG
CAGE Code	D0935	SIEMENS AG
CAGE Code	D0968	SIEMENS AG
CAGE Code	D1178	SIEMENS AG
CAGE Code	D1179	SIEMENS AG
CAGE Code	D1181	SIEMENS AG
CAGE Code	D2669	SIEMENS AG
CAGE Code	D2739	SIEMENS AG
CAGE Code	D8010	SIEMENS AG
CAGE Code	DK374	SIEMENS AG
CAGE Code	DK654	SIEMENS AG RD INDUSTRIAL SOLUTIONS AND SERVICES
CAGE Code	D0279	SIEMENS AG
CAGE Code	D9698	SIEMENS AG
CAGE Code	D1173	SIEMENS AG
CAGE Code	D1176	SIEMENS AG
CAGE Code	CH760	SIEMENS AG
SEC	0000940418	SIEMENS AG

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092948422	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ELECTRICAL APPLIANCES AS HS-CODE 850153 HBL BANQBRE4454248	2 PKG
2020092948420	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ELECTRICAL APPLIANCES AS HS-CODE 850153 HBL BANQBRE4454215	1 PKG
2020092948425	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ELECTRICAL APPLIANCES AS HS-CODE 850153 HBL BANQBRE4454636	2 PKG
2020092858116	Bremerhaven,Federal Republic of Germany -> Savannah, Georgia	ELECTRICAL APPLIANCES HS CODE 848390 HBL BANQBRE4485284	1 PKG
2020092674028	Xcalac,Mexico -> Houston, Texas	TRIPHASE ELECTRIC MOTOR	22 BOX
2020092674041	Xcalac,Mexico -> Houston, Texas	TRIPHASE ELECTRIC MOTOR	2 BOX
2020092552415	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	.	3 CAS
2020092552430	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	LITHIUM METAL BATTERIES 188	1 CAS