Siemens Healthcare Diagnostics Inc. (specification developer, Tarrytown, NY): 9 new FDA device listings, incl. test, epithelial ovarian tumor-associated antigen (ca125)
Siemens Healthcare Diagnostics Inc. (Tarrytown, New York): 9 new FDA device listings, incl. test, epithelial ovarian tumor-associated antigen (ca125). Its amount of 9 is top-decile (92nd percentile of 2,709 records). Dated 70 days ago, it serves as a historical benchmark. Score 85/100. As of 2026-11-04, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 9 · 92th percentile of 2,709 DeviceEstablishmentPulse records · 4.5x the median
Free preview: all 14 published fields of this record are shown below. Locked: 57 related NY DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Siemens Healthcare Diagnostics Inc. |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Complaint File Establishment per 21 CFR 820.198; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Tarrytown, NY, US |
| New listings | 9 |
| Devices | Test, Epithelial Ovarian Tumor-Associated Antigen (Ca125); System, Test, Carcinoembryonic Antigen; Bilirubin (Total And Unbound) In The Neonate Test System; Diazo Colorimetry, Bilirubin; System, Test, Carbohydrate Antigen (Ca19-9), For Monitoring And Management Of Pancreatic Cancer; Single (Specified) Analyte Controls (Assayed And Unassayed); System, Test, Immunological, Antigen, Tumor; Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions; Colorimetry, Acetaminophen |
| Product codes | LTK, DHX, MQM, CIG, NIG, JJX, MOI, MTG, LDP |
| Device classes | Class I, Class II, Class III |
| Medical specialties | Immunology, Clinical Chemistry, Clinical Toxicology |
| Brand names | ADVIA Centaur CA 125II (CA 125II); Atellica IM CA 125II (CA 125II); Atellica IM Carcinoembryonic Antigen (CEA); ADVIA Centaur Carcinoembryonic Antigen (CEA); Atellica CH Diazo Total Bilirubin (D_TBil); Atellica IM CA 19-9 II (CA 19-9 II); IMMULITE 2000 BR-MA; Atellica IM free PSA II (fPSAII) |
| First new listing | 2026-05-19 |
| Latest new listing | 2026-08-27 |
| FDA registration number | 2432235 |
| Registration expires | 2027-12-31 |
| amount percentile | 92th of 2,709 (median 2, 4.5x median) |
| Peer records CSV (58 NY records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-27
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 04 Nov 2026 21:52:36 GMT
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Peer benchmark and outreach value: Siemens Healthcare Diagnostics Inc. and 58 New York peers
- New York DeviceEstablishmentPulse records like this one: 58
- Siemens Healthcare Diagnostics Inc.'s amount: 92nd percentile of 2,709 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every New York peer: $11,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
85 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Siemens Healthcare Diagnostics Inc. in Tarrytown, New York?
Siemens Healthcare Diagnostics Inc. (Tarrytown, NY), a specification developer (outsources manufacturing), added 9 FDA device listings between 2026-05-19 and 2026-08-27.
How does Siemens Healthcare Diagnostics Inc. compare to other New York DeviceEstablishmentPulse records?
This is a top-decile record: its amount of 9 is 4.5x the median of 2 across 2,709 records. It is 70 days old; check the official source for later updates before acting. Its Score of 85/100 puts it among the stronger signals in this feed.
Siemens Healthcare Diagnostics Inc. vs. top 3 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY | 9 | 92nd | 2026-08-27 |
| Boston Scientific Corporation | Marlborough, MA | 9 | 92nd | 2026-10-16 |
| Synthes (USA) Products LLC | West Chester, PA | 7 | 90th | 2026-10-23 |
| SHOULDER INNOVATIONS, Inc | Grand Rapids, MI | 7 | 90th | 2026-10-15 |
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DeviceEstablishmentPulse: Specification developer (outsources manufacturing) DeviceEstablishmentPulse: U.S. establishment DeviceEstablishmentPulse: records in New York
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.