# Bio-Med USA, Inc.

- Location (FDA's records): Paterson, NJ
- FDA decisions: 11 (2008–2022): 11 510(k) clearances
- Names in FDA's records: Bio-Med USA, Inc. (10); Bio-Med USA (1)
- Product codes: GEX (6), FMF (2), LBI (1), ODR (1), ONG (1)
- 510(k) review time since 2016: median 84 days, against 107 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 20 (0 its own); citations of its devices by later devices: 3 (0 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
- Lutronic Corporation: 2 (https://510kreport.com/company/lutronic)
- BLUECORE COMPANY Co., Ltd.: 2 (https://510kreport.com/company/bluecore)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 2 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)
- Terumo Medical Corp.: 2 (https://510kreport.com/company/terumo-medical)
- Hoya Conbio, Inc.: 1 (https://510kreport.com/company/hoya-conbio)
- Atom Medical Corporation: 1 (https://510kreport.com/company/atom-medical)
- Alma Lasers, Inc.: 1 (https://510kreport.com/company/alma-lasers)
- Dornier Medtech America, Inc.: 1 (https://510kreport.com/company/dornier-medtech-america)

## Firms that cite its devices most
- Ami, Inc.: 1 (https://510kreport.com/company/ami)
- Alma, Inc.: 1 (https://510kreport.com/company/alma)
- Nipro Medical Corporation: 1 (https://510kreport.com/company/nipro-medical)

## Its most-cited devices
- K133774: Atoven (2014), cited by 1
- K123710: Unitox Botox Syringe (2013), cited by 1
- K111831: MX-7000 Microxel (2011), cited by 1

## Recent decisions
- K221789: IRIS Pi Q switched Nd YAG laser (Aug 9, 2022)
- K212082: Picore (Oct 6, 2021)
- K182270: Cellene CO2 Laser System (Nov 2, 2018)
- K163638: Dental 5 Multi Diode laser (May 15, 2017)
- K142332: BT-400 (Mar 20, 2015)
- K140837: Lucid LY (Sep 24, 2014)
- K133774: Atoven (Jun 6, 2014)
- K123710: Unitox Botox Syringe (May 9, 2013)

Source page: https://510kreport.com/company/bio-med-usa