# FMD Co., Ltd.

- Location (FDA's records): Shibuya-Ku, JP
- FDA decisions: 5 (2003–2026): 5 510(k) clearances
- Names in FDA's records: FMD Co., Ltd. (3); Fmd, LLC (2)
- Product codes: DQX (3), LNS (2)
- 510(k) review time since 2016: median 118 days, against 145 for FDA's reviews in the same codes and years (2 of 3 faster)
- Predicates its devices cite: 5 (2 its own); citations of its devices by later devices: 4 (2 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
- Edap Technomed, Inc.: 1 (https://510kreport.com/company/edap-technomed)
- Pck Electronic Industry and Trade Co, Ltd.: 1 (https://510kreport.com/company/pck-electronic-industry-and-trade)
- Asahi Intecc Co., Ltd.: 1 (https://510kreport.com/company/asahi-intecc)

## Firms that cite its devices most
- Edap Tms France: 1 (https://510kreport.com/company/edap-tms-france)
- Direx Systems Corp.: 1 (https://510kreport.com/company/direx-systems)

## Its most-cited devices
- K030346: Twinheads TH-101 Extracorporeal Shock Wave Lithotripter (2003), cited by 3
- K212268: FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT (2022), cited by 1

## Recent decisions
- K260544: FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40 (Mar 20, 2026)
- K240460: FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259) (Jun 13, 2024)
- K212268: FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT (May 27, 2022)
- K042561: Twinheads TH-103 Extracorporeal Shock Wave Lithotripter (Oct 12, 2004)
- K030346: Twinheads TH-101 Extracorporeal Shock Wave Lithotripter (May 2, 2003)

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