# Greiner Bio-One North America, Inc.

- Location (FDA's records): Baldwin, MD
- FDA decisions: 10 (2006–2024): 10 510(k) clearances
- Product codes: FMI (5), JKA (5)
- Predicates its devices cite: 13 (3 its own); citations of its devices by later devices: 10 (3 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Greiner Bio-One Vacuette North America: 3 (https://510kreport.com/company/greiner-bio-one-vacuette-north-america)
- Greiner Meditech, Inc.: 2 (https://510kreport.com/company/greiner-meditech)
- Greiner Vacuette North America, Inc.: 2 (https://510kreport.com/company/greiner-vacuette-north-america)
- Jiangsu Caina Medical Co.,Ltd: 1 (https://510kreport.com/company/jiangsu-caina-medical)
- Smiths Medical Asd, Inc.: 1 (https://510kreport.com/company/smiths-medical-asd)
- Bd Becton Dickinson Vacutainer Systems Preanalytic: 1 (https://510kreport.com/company/bd-becton-dickinson-vacutainer-systems-preanalytic)

## Firms that cite its devices most
- Nsp Tech Pte, Ltd.: 1 (https://510kreport.com/company/nsp-tech)
- Greiner Bio-One Na, Inc.: 1 (https://510kreport.com/company/greiner-bio-one-na)
- Shandong Weigao Group Medical Polymer Co., Ltd.: 1 (https://510kreport.com/company/shandong-weigao-group-medical-polymer)
- Myco Medical Supplies, Inc.: 1 (https://510kreport.com/company/myco-medical-supplies)
- Becton, Dickinson & CO: 1 (https://510kreport.com/company/becton-dickinson)
- International Medsurg Connection: 1 (https://510kreport.com/company/international-medsurg-connection)
- Gemtier Medical (Shanghai), Inc.: 1 (https://510kreport.com/company/gemtier-medical-shanghai)

## Its most-cited devices
- K061483: Vacuette Visio Plus Blood Collection Needles (2006), cited by 3
- K121908: Safety Infusion Set (2012), cited by 2
- K122687: Blood Culture Holder (2013), cited by 2
- K072320: Greiner Vacuette Quickshield Complete (2007), cited by 1
- K102774: Vacuette Quickshield with Snappy Tude Holder (2010), cited by 1
- K113505: Vacuette Quickshield with Snappy Tube Holder (2012), cited by 1

## Recent decisions
- K233979: VACUETTE® QUICKSHIELD Complete (Plus) (Jul 19, 2024)
- K122687: Blood Culture Holder (Jan 10, 2013)
- K121908: Safety Infusion Set (Jul 25, 2012)
- K113505: Vacuette Quickshield with Snappy Tube Holder (Feb 17, 2012)
- K103041: Vacuette Blood Collection Tube with Lithium Heparin and Gel Separator (Nov 9, 2010)
- K102774: Vacuette Quickshield with Snappy Tude Holder (Oct 15, 2010)
- K081929: Vacuette Blood Collection Tube with Clot Activator and Gel Separator (Dec 16, 2008)
- K072320: Greiner Vacuette Quickshield Complete (Sep 14, 2007)

Source page: https://510kreport.com/company/greiner-bio-one-north-america