Siemens Healthcare L T D

FDA Filings

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

FDA Registration(s)

• Registration Number: 3012127758
• FEI Number: 3012127758
• Name: Siemens Healthcare Limited
• Owner & Operator: SIEMENS MEDICAL SOLUTIONS USA, INC.
• Contact Address: 40 Liberty Boulevard Mail Code: 65-1A; Malvern PA 19355 US
• Official Correspondent:
  • Robert Z Phillips
  • x-302-6319702-x
• US Agent:
  • Robert Z Phillips
  • SIEMENS MEDICAL SOLUTIONS USA, INC.
  • 302 6319702
  • 610 4486487
  • robert.z.phillips@siemens-healthineers.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 1577 North Service Road East ; Oakville Ontario, L6H 0H6 CA
• Establishment Type: Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
PMN K123938 | LNH Siemens Healthcare Limited [SIEMENS MEDICAL SOLUTIONS USA, INC.]	Software syngo MR 819 for MAGNETOM Avanto, Espree,Symphony A Tim System, Trio A Tim System, and Verio	2019-08-09
PMN K091536 | LNH Siemens Healthcare Limited [SIEMENS MEDICAL SOLUTIONS USA, INC.]	GE Optima MR 450	2018-12-05

Similar & Related FDA Registered Companies

• Siemens Healthcare Diagnostics Products Ltd.
• 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 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 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 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 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 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.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 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 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 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 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 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 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 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 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.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 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 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

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020011739699	Stadersand,Federal Republic of Germany -> Norfolk, Virginia	ARTIS Q CEILING NEURO HEAD HOLDER FOR ANGIOGRAPHY INVOICE 584K0133547742 584K0133546000 HS CODE	19 PCS
201812264381	Vancouver, BC ,Canada -> Oakland, California	1X40HC CONTAINER S SOMATOM DEFINITION EDGE I	13 PCS
2018022656446	Stadersand,Federal Republic of Germany -> Savannah, Georgia	MEDICAL EQUIPMENT ARTIS ZEE MP (PURE) LITHIUM ION BATTERIES IN WITH SP 188 IMDG-CODE, SEE DOCUMENT THAT ACCOMPANIES THE SHIPMENT HS-CODE 90221400	14 PCS