# Orbusneich Medical, Inc.

- Location (FDA's records): Fort Lauderdale, FL
- FDA decisions: 4 (2011–2017): 4 510(k) clearances
- Product codes: LOX (4)
- Predicates its devices cite: 12 (4 its own); citations of its devices by later devices: 10 (4 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
- Medtronic, Ireland: 2 (https://510kreport.com/company/medtronic-ireland)
- Advanced Cardiovascular Systems, Inc.: 2 (https://510kreport.com/company/advanced-cardiovascular-systems)
- Scimed Life Systems, Inc.: 2 (https://510kreport.com/company/scimed-life-systems)
- Cordis Corp.: 2 (https://510kreport.com/company/cordis)

## Firms that cite its devices most
- Orbusneich Medical Trading, Inc.: 2 (https://510kreport.com/company/orbusneich-medical-trading)
- Dongguan TT Medical, Inc.: 1 (https://510kreport.com/company/dongguan-tt-medical)
- Kossel Medtech (Suzhou) Co., Ltd.: 1 (https://510kreport.com/company/kossel-medtech-suzhou)
- OrbusNeich Medical (Shenzhen) Co., Ltd.: 1 (https://510kreport.com/company/orbusneich-medical-shenzhen)
- Medcaptain Life Science Co., Ltd.: 1 (https://510kreport.com/company/medcaptain-life-science)

## Its most-cited devices
- K162209: Sapphire NC Plus (2016), cited by 3
- K103808: Sapphire NC (2011), cited by 3
- K163114: Sapphire II PRO (2017), cited by 3
- K103657: Sapphire (2011), cited by 1

## Recent decisions
- K163114: Sapphire II PRO (Jan 5, 2017)
- K162209: Sapphire NC Plus (Oct 6, 2016)
- K103808: Sapphire NC (Sep 1, 2011)
- K103657: Sapphire (Aug 9, 2011)

Source page: https://510kreport.com/company/orbusneich-medical