Not currently registered with FDA under this name

Siemens Medical Solutions USA, Inc.

Iselin, NJ, United States. Named as applicant on 3 dental 510(k) clearances between 1984 and 1989. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
31984–1989
Markets registered in
6123 registrations outside the US
Establishments
0—
1984: 11987: 11989: 119801990200020102020

510(k) clearances per year, 1980–2026

Registered in 6 markets

Where regulators' registries name Siemens Medical Solutions USA, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 3 clearancesTaiwan: 40 registrationsIsrael: 33 registrationsPeru: 26 registrationsBrazil: 22 registrationsColombia: 2 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantSiemens Medical Solutions USA, Inc.3 clearances1984–1989Below
TaiwanTFDAManufacturerSiemens Medical Solutions USA, Inc.SIEMENS MEDICAL SOLUTIONS USA, INC. · Siemens Medical Solutions USA, Inc · +1402004–2024Pure Global AI
IsraelAMARManufacturerSIEMENS Medical solutions USA, IncSiemens Medical Solutions USA, Inc. · Siemens Medical Solutions USA, Inc · +233—Pure Global AI
PeruDIGEMIDManufacturerSIEMENS MEDICAL SOLUTIONS USA INC.SIEMENS MEDICAL SOLUTIONS USA · SIEMENS MEDICAL SOLUTIONS USA, INC.262010–2026Pure Global AI
BrazilANVISAManufacturerSIEMENS MEDICAL SOLUTIONS USA, INC.SIEMENS MEDICAL SOLUTIONS USA INC · SIEMENS MEDICAL SOLUTIONS USA, INC222010–2025Pure Global AI
ColombiaINVIMAManufacturerSIEMENS MEDICAL SOLUTIONS USA, INC.2—Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

510(k) clearances

Clearances on which FDA names Siemens Medical Solutions USA, Inc. as the applicant.

Decided510(k)DeviceDevice type
17 Nov 1989K895467ORTHOPHOS AND ORTHOPHOS CEHD Extraoral with Timer X-Ray Unit
23 Jun 1987K872171PERIOTESTEKX Ac-Powered Direct Drive Handpiece
14 Nov 1984K843951SIROGNATHOGRAPHNFS Jaw Tracking Device for Monitoring Jaw Positions

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.