Siemens AG: FDA filings under this applicant name

FDA lists 15 510(k) clearances under the applicant name “Siemens AG” (first 1995, latest 2015), across 9 product codes in 2 review panels. Median 510(k) review time under this name: 48 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Siemens Healthineers, based on public ownership records.

510(k) clearances per year

Top product codes

Review panels

• Radiology (12)
• Dental (3)

Most recent Siemens AG 510(k) clearances

5 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Siemens AG.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Related HCPCS codes

HCPCS Level II codes whose descriptors match the device names of the product codes filed under Siemens AG (a text match, not an official crosswalk):

• C8900 — Magnetic resonance angiography with contrast, abdomen (via MOS)
• C8901 — Magnetic resonance angiography without contrast, abdomen (via MOS)
• C8918 — Magnetic resonance angiography with contrast, pelvis (via MOS)
• C8919 — Magnetic resonance angiography without contrast, pelvis (via MOS)
• C8902 — Magnetic resonance angiography without contrast followed by with contrast, abdomen (via MOS)

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Siemens Medical Solutions USA, Inc. (784 510(k)s)
• Siemens Healthcare Diagnostics, Inc. (245 510(k)s)
• Siemens Corp. (67 510(k)s)
• Siemens Elema AB (63 510(k)s)
• Siemens Gammasonics, Inc. (53 510(k)s)
• Siemens Hearing Instruments, Inc. (42 510(k)s)
• Siemens Medi Cal Solutions, Inc. (32 510(k)s)
• Siemens AG Medical Solutions (31 510(k)s)
• Siemens Healthcare GmbH (31 510(k)s)
• Siemens Medical Systems, Inc. (25 510(k)s)
• Siemens Healthcare Diagnostics Products GmbH (18 510(k)s)
• Siemens Medical Electronics (15 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Siemens AG?

FDA lists 15 510(k) clearances under the applicant name “Siemens AG” (first 1995, latest 2015), across 9 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Siemens AG?

The median time from FDA receipt to decision across 510(k)s cleared under the name Siemens AG is 48 days.

Which FDA product codes appear under Siemens AG?

The most frequent FDA product codes under this applicant name are JAK (System, X-Ray, Tomography, Computed, 5); LLZ (System, Image Processing, Radiological, 3); EFA (Handpiece, Belt And/Or Gear Driven, Dental, 1).

Next steps

• See all 15 Siemens AG clearances with predicates and recalls
• Run predicate analysis for product code JAK, Siemens AG's most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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