# Coreleader Biotech Co., Ltd.

- Location (FDA's records): Taipei, Taiwan, TW
- FDA decisions: 9 (2011–2015): 9 510(k) clearances
- Product codes: FRO (5), QSY (2), KGN (1), MDA (1)
- Predicates its devices cite: 21 (0 its own); citations of its devices by later devices: 2 (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
- Calgon Vestal Div.: 4 (https://510kreport.com/company/calgon-vestal-div)
- Johnson & Johnson Medical, Inc.: 2 (https://510kreport.com/company/johnson-johnson-medical)
- Integra LifeSciences Corporation: 2 (https://510kreport.com/company/integra-lifesciences)
- Coloplast Corp.: 2 (https://510kreport.com/company/coloplast)
- Scion Cardio-Vascular, Inc.: 1 (https://510kreport.com/company/scion-cardio-vascular)
- Abbott Vascular: 1 (https://510kreport.com/company/abbott-vascular)
- T-Scientific, Inc.: 1 (https://510kreport.com/company/t-scientific)
- Maxigen Biotech, Inc.: 1 (https://510kreport.com/company/maxigen-biotech)

## Firms that cite its devices most
- Advamedica, Inc.: 1 (https://510kreport.com/company/advamedica)
- Innotherapy, Inc.: 1 (https://510kreport.com/company/innotherapy)

## Its most-cited devices
- K102944: Coreleader Hemo-Pad Model Cpii 02030 (2011), cited by 2

## Recent decisions
- K151204: HEMO-Bandage (Jul 31, 2015)
- K141382: Bios King Biocellulose Film (Feb 10, 2015)
- K123394: Coreleader Hydro-Healer Hydrocolloid Wound Dressing (Jun 6, 2013)
- K111578: Coreleader Colla-Algi Fiber Model Caw (Sep 23, 2011)
- K111733: Coreleader Scar-Dimmer (Sep 22, 2011)
- K102944: Coreleader Hemo-Pad Model Cpii 02030 (Sep 7, 2011)
- K102942: Coreleader Algiplaster Model AP 050501 (Jun 22, 2011)
- K102946: Coreleader Colla-Pad Model CS 03030 (May 20, 2011)

Source page: https://510kreport.com/company/coreleader-biotech