# I.E.M. GmbH

- Location (FDA's records): Stolberg, DE
- FDA decisions: 5 (2004–2016): 5 510(k) clearances
- Product codes: DXN (5)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 8 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Atcor Medical: 1 (https://510kreport.com/company/atcor-medical)
- Omron Healthcare, Inc.: 1 (https://510kreport.com/company/omron-healthcare)
- Industrielle Entwicklung Medizintechnik Und Vertri: 1 (https://510kreport.com/company/industrielle-entwicklung-medizintechnik-und-vertri)

## Firms that cite its devices most
- Card Guard Scientific Survival, Ltd.: 1 (https://510kreport.com/company/card-guard-scientific-survival)
- I.E.M. Industrielle Entwicklung and Medizintechnik: 1 (https://510kreport.com/company/iem-industrielle-entwicklung-and-medizintechnik)
- Suntech Medical, Inc.: 1 (https://510kreport.com/company/suntech-medical)
- Pulsecor Limited: 1 (https://510kreport.com/company/pulsecor)
- Healthstats International Pte., Ltd.: 1 (https://510kreport.com/company/healthstats-international)

## Its most-cited devices
- K110603: Hypertension Management Software Claient Server (HMS-CS) (2011), cited by 3
- K041313: Stabil-O-Graph (2004), cited by 2
- K140928: ABPM7100 (2014), cited by 2
- K072446: Mobil-O-Graph NG 24 H Abp-Control (2007), cited by 1

## Recent decisions
- K153557: ABPM 7100, Hypertension Management Software (Jul 19, 2016)
- K140928: ABPM7100 (Sep 15, 2014)
- K110603: Hypertension Management Software Claient Server (HMS-CS) (Dec 16, 2011)
- K072446: Mobil-O-Graph NG 24 H Abp-Control (Nov 29, 2007)
- K041313: Stabil-O-Graph (Jun 18, 2004)

Source page: https://510kreport.com/company/iem