Siemens Healthcare G M B H

FDA Filings

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

FDA Registration(s)

• Registration Number: 3006894636
• FEI Number: 3006894636
• Name: Siemens Healthcare GmbH
• Owner & Operator: Siemens AG/Siemens Healthcare GmbH
• Contact Address: Henkestrasse 127 --; Erlangen DE-NOTA 91052 DE
• US Agent:
  • Robert Phillips
  • 302 2359839
  • robert.z.phillips@siemens.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: CR Radiation Oncology (RO) Doris-Ruppenstein-Str. 4; Erlangen Bayern, 91052 DE
• Establishment Type:
  • Develop Specifications But Do Not Manufacture At This Facility
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

• Registration Number: 3011194542
• FEI Number: 3011194542
• Name: Siemens Healthcare GmbH
• Owner & Operator: SIEMENS HEALTHCARE DIAGNOSTICS INC.
• Contact Address: Siemens Healthcare Diagnostics Inc. 500, GBC Drive; Newark DE 19702 US
• Official Correspondent:
  • Marilyn Waxberg
  • 1-484-9016348-x
• US Agent:
  • Thomas Myers
  • Siemens Healthcare Diagnostics,, Inc.
  • 574 3068608
  • thomas.myers@siemens-healthineers.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Am Studio 1 ; Berlin Berlin, 12489 DE
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID 04056869964539 Siemens Healthcare GmbH	syngo Application Software	2024-11-25
GUDID 04056869985558 Siemens Healthcare GmbH	MAGNETOM Viato.Mobile	2024-07-01
GUDID 04056869962801 Siemens Healthcare GmbH	SOMATOM Pro.Pulse	2024-06-18
GUDID 04068151001075 Siemens Healthcare GmbH	Syngo Carbon Enterprise Access	2024-06-11
GUDID 04056869279619 Siemens Healthcare GmbH	CIARTIC Move	2024-05-09
GUDID 04056869987187 Siemens Healthcare GmbH	MAMMOMAT B.brilliant	2024-04-29
GUDID 04056869996172 Siemens Healthcare GmbH	AI-Rad Companion (Pulmonary)	2024-04-15
GUDID 04056869964331 Siemens Healthcare GmbH	AI-Rad Companion (Pulmonary)	2024-04-09
GUDID 04056869973135 Siemens Healthcare GmbH	MAGNETOM Terra.X Upgrade	2024-04-03
GUDID 04056869961491 Siemens Healthcare GmbH	MAGNETOM Terra.X	2024-04-03
GUDID 04056869975238 Siemens Healthcare GmbH	MAGNETOM Cima.X Fit	2024-03-13
GUDID 04056869991269 Siemens Healthcare GmbH	syngo Virtual Cockpit	2024-01-24
GUDID 04056869985947 Siemens Healthcare GmbH	Syngo Carbon Clinicals	2024-01-11
GUDID 04056869964546 Siemens Healthcare GmbH	syngo Application Software	2024-01-09
GUDID 04056869975245 Siemens Healthcare GmbH	MAGNETOM Cima.X	2023-12-29
GUDID 04056869975221 Siemens Healthcare GmbH	MAGNETOM Cima.X	2023-12-29
GUDID 04056869267340 Siemens Healthcare GmbH	syngo.CT Dual Energy	2023-12-27
GUDID 04056869966922 Siemens Healthcare GmbH	syngo.CT Dual Energy	2023-12-26
GUDID 04056869952697 Siemens Healthcare GmbH	syngo Carbon Space	2023-12-04
GUDID 04056869968278 Siemens Healthcare GmbH	AI-Rad Companion Brain MR	2023-11-29
GUDID 04056869984681 Siemens Healthcare GmbH	Upgrade Kit XA60A	2023-11-14
GUDID 04056869964386 Siemens Healthcare GmbH	Chondral Quant	2023-07-25
GUDID 04056869976907 Siemens Healthcare GmbH	syngo Carbon Space	2023-07-06
GUDID 04056869953014 Siemens Healthcare GmbH	syngo.MR Applications	2023-03-27
GUDID 04056869984735 Siemens Healthcare GmbH	syngo Dynamics	2023-03-24
GUDID 04056869960739 Siemens Healthcare GmbH	syngo.via View&GO	2023-03-20
GUDID 04056869297286 Siemens Healthcare GmbH	AI-Rad Companion (Cardiovascular)	2023-03-20
GUDID 04056869288475 Siemens Healthcare GmbH	syngo.via View&GO	2023-03-20
GUDID 04056869968896 Siemens Healthcare GmbH	syngo Dynamics	2023-03-17
GUDID 04056869287362 Siemens Healthcare GmbH	syngo Dynamics	2023-03-17
GUDID 04056869267456 Siemens Healthcare GmbH	syngo.CT Brain Hemorrhage	2022-12-08
GUDID 04056869299266 Siemens Healthcare GmbH	MAGNETOM Avanto Fit	2022-12-07
GUDID 04056869955667 Siemens Healthcare GmbH	AI-Rad Companion Organs RT	2022-11-17
GUDID 04056869287416 Siemens Healthcare GmbH	syngo.CT Applications	2022-11-02
GUDID 04056869287393 Siemens Healthcare GmbH	syngo.via RT Image Suite	2022-11-02
GUDID 04056869287386 Siemens Healthcare GmbH	syngo.CT Extended Functionality	2022-11-02
GUDID 04056869262567 Siemens Healthcare GmbH	syngo Application Software	2022-10-18
PMN K221501 Siemens Healthcare GmBH	Syngo.via View&GO	2022-10-14
GUDID 04056869295923 Siemens Healthcare GmbH	ARTIS icono ceiling	2022-10-10
GUDID 04056869297279 Siemens Healthcare GmbH	AI-Rad Companion (Pulmonary)	2022-10-06
PMN K213713 Siemens Healthcare GmBh	AI-Rad Companion (Pulmonary)	2022-08-11
GUDID 04056869298207 Siemens Healthcare GmbH	AI-Rad Companion Brain MR	2022-06-10
GUDID 04056869299273 Siemens Healthcare GmbH	MAGNETOM Skyra Fit	2022-05-27
PMN K213706 Siemens Healthcare GmBh	AI-Rad Companion Brain MR	2022-04-15
GUDID 04056869281230 Siemens Healthcare GmbH	MAMMOVISTA B.smart	2022-02-18
GUDID 04056869296210 Siemens Healthcare GmbH	syngo.MR Applications	2022-01-27
GUDID 04056869285801 Siemens Healthcare GmbH	syngo.via	2022-01-24
GUDID 04056869955575 Siemens Healthcare GmbH	MAMMOVISTA B.smart	2021-12-22
GUDID 04056869247175 Siemens Healthcare GmbH	syngo Dynamics VA20G Packaging Label	2021-11-17
GUDID 04056869247144 Siemens Healthcare GmbH	syngo Dynamics VA20G	2021-11-17
GUDID 04056869263168 Siemens Healthcare GmbH	NAEOTOM Alpha	2021-10-21
GUDID 04056869267425 Siemens Healthcare GmbH	syngo.via RT Image Suite	2021-09-29
GUDID 04056869252230 Siemens Healthcare GmbH	syngo.CT Extended Functionality	2021-09-29
GUDID 04056869231051 Siemens Healthcare GmbH	SOMATOM X.ceed	2021-09-28
GUDID 04056869267463 Siemens Healthcare GmbH	syngo.CT Skull Unfolding	2021-09-13
GUDID 04056869274645 Siemens Healthcare GmbH	AI-Rad Companion Organs RT	2021-08-16
GUDID 04056869274638 Siemens Healthcare GmbH	Ai-Rad Companion Prostate MR	2021-08-16
GUDID 04056869274621 Siemens Healthcare GmbH	AI-Rad Companion Brain MR	2021-08-16
GUDID 04056869267258 Siemens Healthcare GmbH	Contour S Coil Set	2021-08-10
GUDID 04056869267241 Siemens Healthcare GmbH	Contour S Coil	2021-08-10
GUDID 04056869267234 Siemens Healthcare GmbH	BM Contour L Coil	2021-08-10
GUDID 04056869267227 Siemens Healthcare GmbH	BM Contour L Coil set 0.55T	2021-08-10
GUDID 04056869148663 Siemens Healthcare GmbH	UltraFlex Large 18	2021-08-09
GUDID 04056869148656 Siemens Healthcare GmbH	UltraFlex Small 18	2021-08-09
GUDID 04056869148649 Siemens Healthcare GmbH	UltraFlex Large 18 Coil Set 1.5T	2021-08-09
GUDID 04056869148632 Siemens Healthcare GmbH	UltraFlex Small 18 Coil Set 1.5T	2021-08-09
GUDID 04056869260143 Siemens Healthcare GmbH	MAGNETOM Vida	2021-07-19
GUDID 04056869260136 Siemens Healthcare GmbH	MAGNETOM Lumina	2021-07-19
GUDID 04056869230726 Siemens Healthcare GmbH	MAGNETOM Altea	2021-07-19
GUDID 04056869217864 Siemens Healthcare GmbH	MAGNETOM Sola	2021-07-19
GUDID 04056869263045 Siemens Healthcare GmbH	SOMATOM On.site	2021-05-27
PMN K203258 Siemens Healthcare GmbH	Syngo.CT Lung CAD	2021-03-31
GUDID 04056869251226 Siemens Healthcare GmbH	AI-Rad Companion (Cardiovascular)	2021-03-17
GUDID 04056869251202 Siemens Healthcare GmbH	AI-Rad Companion (Engine)	2021-03-17
GUDID 04056869251233 Siemens Healthcare GmbH	AI-Rad Companion (Musculoskeletal)	2021-03-16
GUDID 04056869251219 Siemens Healthcare GmbH	AI-Rad Companion (Pulmonary)	2021-03-16
GUDID 04056869257969 Siemens Healthcare GmbH	AI-Rad Companion Organs RT	2021-02-26
GUDID 04056869257952 Siemens Healthcare GmbH	AI-Rad Companion Prostate MR	2021-02-26
GUDID 04056869257921 Siemens Healthcare GmbH	AI-Rad Companion Engine	2021-02-11
GUDID 04056869246628 Siemens Healthcare GmbH	Cios Flow	2021-02-09
GUDID 04056869257945 Siemens Healthcare GmbH	AI-Rad Companion Brain MR	2020-12-18
GUDID 04056869269931 Siemens Healthcare GmbH	LUMINOS Lotus Max	2020-11-09
GUDID 04056869232904 Siemens Healthcare GmbH	YSIO X.pree	2020-11-09
GUDID 04056869272320 Siemens Healthcare GmbH	syngo Dynamics	2020-11-06
GUDID 04056869272313 Siemens Healthcare GmbH	syngo Dynamics	2020-11-06
GUDID 04056869259802 Siemens Healthcare GmbH	syngo.via	2020-10-08
GUDID 04056869151571 Siemens Healthcare GmbH	SOMATOM go.Top	2020-09-07
GUDID 04056869151564 Siemens Healthcare GmbH	SOMATOM go.All	2020-09-07
GUDID 04056869051314 Siemens Healthcare GmbH	SOMATOM go.Up	2020-09-07
GUDID 04056869051291 Siemens Healthcare GmbH	SOMATOM go.Now	2020-09-07
GUDID 04056869259901 Siemens Healthcare GmbH	syngo Dynamics	2020-07-22
GUDID 04056869256399 Siemens Healthcare GmbH	syngo Dynamics	2020-07-22
GUDID 04056869249247 Siemens Healthcare GmbH	SOMATOM go.Open Pro	2020-07-22
GUDID 04056869270142 Siemens Healthcare GmbH	syngo.via View&GO (Version VA20A)	2020-07-16
GUDID 04056869010090 Siemens Healthcare GmbH	Artis zee floor MN	2020-07-02
GUDID 04056869008998 Siemens Healthcare GmbH	SIREMOBIL Compact L	2020-07-02
PMN K201477 Siemens Healthcare GmbH	Syngo.via View&GO	2020-07-01
GUDID 04056869245188 Siemens Healthcare GmbH	MAGNETOM Vida Fit	2020-03-31
GUDID 04056869230740 Siemens Healthcare GmbH	MAGNETOM Lumina	2020-03-24
GUDID 04056869039176 Siemens Healthcare GmbH	MAGNETOM Vida	2020-03-24
GUDID 04056869245195 Siemens Healthcare GmbH	MAGNETOM Sola Fit	2020-03-12
GUDID 04056869230719 Siemens Healthcare GmbH	MAGNETOM Altea	2020-03-12
GUDID 04056869164809 Siemens Healthcare GmbH	MAGNETOM Sola	2020-03-05
GUDID 04056869230214 Siemens Healthcare GmbH	syngo.MR Applications	2020-02-14
GUDID 04056869039190 Siemens Healthcare GmbH	MAGNETOM Terra	2020-02-12
PMN K191040 Siemens Healthcare GmbH	Syngo.via (Version VB40A)	2019-05-16
PMN K182208 Siemens Healthcare GmbH	Syngo.via View&GO (Version VA10A)	2018-09-07
PMN K180563 Siemens Healthcare GmbH	Syngo.plaza	2018-04-25
PMN K173625 | JAK Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	syngo.CT Clinical Extensions	2018-04-18
PMN K173378 Siemens Healthcare GmbH	Syngo®.via ProtoNeo (Version VA20)	2017-11-20
PMN K993425 | IYE Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	PRIMUS	2017-06-21
PMN K910971 | JAI Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	ZXT RADIATION THER	2017-06-21
PMN K123812 | IYE Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	ONCOR / PRIMUS Linac with ARIA OIS update	2017-06-21
PMN K121295 | IYE Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	ARTISTE Solution with SYS_VC10	2017-06-21
PMN K121295 | IYE Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	ARTISTE Solution V4.3	2017-06-21
PMN K103606 | IYE Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	ARTISTE Solution, V4.2	2017-06-21
PMN K103606 | IYE Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	ARTISTE Solution with SYS_VB50	2017-06-21
PMN K092145 | IYE Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	ONCOR 160 MLC	2017-06-21
PMN K090683 | IYE Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	syngo RTT Connect	2017-06-21
PMN K090683 | IYE Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	COHERENCE RTT Connect	2017-06-21
PMN K171053 Siemens Healthcare GmbH	Syngo Dynamics Version VA30	2017-06-01
PMN K170221 Siemens Healthcare GmbH	Syngo.CT Cardiac Planning	2017-04-21
PMN K161685 SIEMENS HEALTHCARE GMBH	Syngo®.via ProtoNeo (Version VA10A)	2016-07-11
PMN K120363 | MUJ Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	SYNGO RT INTERFACE	2015-12-01
PMN K120363 | LLZ Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	SYNGO RT INTERFACE	2015-12-01
PMN K151887 | MUJ Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	syngo VSim	2015-10-01
PMN K101119 | MUJ Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	syngo Dosimetrist V2.7	2011-04-28
PMN K022307 | MUJ Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	KONRAD TREATMENT PLANNING SOFTWARE	2009-11-06
PMN K072485 | IYE Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	ARTISTE	2009-08-20
PMN K072485 | IYE Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	ARTISTE Solution	2009-08-20
PMN K060226 | IYE Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	ONCOR Expression	2006-07-05
PMN K050422 | JAI Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	550 TXT TREATMENT TABLE	2006-06-22
PMN K032790 | IXI Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	SIEMENS IMFAST	2006-06-22
PMN K032790 | IXI Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	OPTIFOCUS	2006-06-22
PMN K032790 | IXI Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	MODULEAF	2006-06-22
PMN K032790 | IXI Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	MICROMLC	2006-06-22
PMN K032790 | IXI Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	3D MLC	2006-06-22
PMN K031764 | IYE Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	PRIMUS FAMILY	2006-06-22
PMN K031764 | IYE Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	ONCOR FAMILY	2006-06-22
PMN K031764 | IYE Siemens Healthcare GmbH [Siemens AG/Siemens Healthcare GmbH]	ONCOR Avant Garde	2006-06-22
JQP Siemens Healthcare GmbH [SIEMENS HEALTHCARE DIAGNOSTICS INC.]	UniPOC	2000-02-07
JQP Siemens Healthcare GmbH [SIEMENS HEALTHCARE DIAGNOSTICS INC.]	RAPIDComm	2000-02-07
JQP Siemens Healthcare GmbH [SIEMENS HEALTHCARE DIAGNOSTICS INC.]	POCcelerator	2000-02-07
JQP Siemens Healthcare GmbH [SIEMENS HEALTHCARE DIAGNOSTICS INC.]	CentraLink	2000-02-07

Similar & Related FDA Registered Companies

• Siemens Healthcare Diagnostics Products GmbH
• Siemens Healthcare Diagnostic Products Gmbh
• SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH
• 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 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 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 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 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.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 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 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 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 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 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 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 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 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 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 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.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 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

Related Finance Registrations

NCAGE Code	D1323	SIEMENS HEALTHCARE GMBH
CAGE Code	D1323	SIEMENS HEALTHCARE GMBH

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092947094	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ELECTRICAL APPLIANCES LOW VOLTAGE MOTOR HS CODE 853225, 853669, 853890, 850450, 853321, 854110, 853400 HBL BANQBRE4452860	2 PKG
2020092377035	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	ARTIS Q FLOOR HSC:90221400	9 CAS
2020092377035	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	ARTIS Q FLOOR HSC:90221400	9 CAS
2020092377035	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	ARTIS Q FLOOR HSC:90221400	9 CAS
2020092377035	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	ARTIS Q FLOOR HSC:90221400	9 CAS
2020092377035	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	ARTIS Q FLOOR HSC:90221400	9 CAS
2020092377035	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	ARTIS Q FLOOR HSC:90221400	9 CAS
2020092377035	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	ARTIS Q FLOOR HSC:90221400	9 CAS
2020092377035	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	ARTIS Q FLOOR HSC:90221400	9 CAS
2020092377035	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	ARTIS Q FLOOR HSC:90221400	9 CAS
2020092375271	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT,ARTIS Q CEILING LITHIUM ION BATTERIES	16 PKG
2020092343971	Stadersand,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	ELECTRICAL APPLIANCES LOW VOLTAGE MOTOR HS CODE 853225, 853669, 853890, 850450, 853321, 854110, 853400 HBL BANQBRE4452860	2 PKG
2020091965553	Bremerhaven,Federal Republic of Germany -> Houston, Texas	ARTIS PHENO KMAT HSC: 90221400	16 CAS
2020091965553	Bremerhaven,Federal Republic of Germany -> Houston, Texas	ARTIS PHENO KMAT HSC: 90221400	16 CAS
2020091965553	Bremerhaven,Federal Republic of Germany -> Houston, Texas	ARTIS PHENO KMAT HSC: 90221400	16 CAS
2020091965553	Bremerhaven,Federal Republic of Germany -> Houston, Texas	ARTIS PHENO KMAT HSC: 90221400	16 CAS
2020091965553	Bremerhaven,Federal Republic of Germany -> Houston, Texas	ARTIS PHENO KMAT HSC: 90221400	16 CAS
2020091965553	Bremerhaven,Federal Republic of Germany -> Houston, Texas	ARTIS PHENO KMAT HSC: 90221400	16 CAS
2020091965553	Bremerhaven,Federal Republic of Germany -> Houston, Texas	ARTIS PHENO KMAT HSC: 90221400	16 CAS
2020091965553	Bremerhaven,Federal Republic of Germany -> Houston, Texas	ARTIS PHENO KMAT HSC: 90221400	16 CAS
2020091965553	Bremerhaven,Federal Republic of Germany -> Houston, Texas	ARTIS PHENO KMAT HSC: 90221400	16 CAS
2020091965553	Bremerhaven,Federal Republic of Germany -> Houston, Texas	ARTIS PHENO KMAT HSC: 90221400	16 CAS
2020091965553	Bremerhaven,Federal Republic of Germany -> Houston, Texas	ARTIS PHENO KMAT HSC: 90221400	16 CAS
2020091965553	Bremerhaven,Federal Republic of Germany -> Houston, Texas	ARTIS PHENO KMAT HSC: 90221400	16 CAS
2020091965553	Bremerhaven,Federal Republic of Germany -> Houston, Texas	ARTIS PHENO KMAT HSC: 90221400	16 CAS
2020091965553	Bremerhaven,Federal Republic of Germany -> Houston, Texas	ARTIS PHENO KMAT HSC: 90221400	16 CAS
2020091965553	Bremerhaven,Federal Republic of Germany -> Houston, Texas	ARTIS PHENO KMAT HSC: 90221400	16 CAS
2020091965553	Bremerhaven,Federal Republic of Germany -> Houston, Texas	ARTIS PHENO KMAT HSC: 90221400	16 CAS
2020091792825	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	12 PACKAGES MEDICAL EQUIPMENT HS-CODE:902214	12 PKG
2020091792826	Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey	MEDICAL EQUIPMENT HS 902214	20 PKG
2020091669932	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	SOMATOM PERSPECTIVE HSC: 90221200	4 CAS
2020091669932	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	SOMATOM PERSPECTIVE HSC: 90221200	4 CAS
2020091669932	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	SOMATOM PERSPECTIVE HSC: 90221200	4 CAS
2020091669932	Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina	SOMATOM PERSPECTIVE HSC: 90221200	4 CAS