ClearanceBrief
Company ยท JP

FMD Co., Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2026. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
DQXWire, Guide, Catheter3
LNSLithotriptor, Extracorporeal Shock-Wave, Urological2

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Mar 20, 2026K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP
FMD Co., Ltd., JP
DQX
Jun 13, 2024K240460FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)
FMD Co., Ltd., JP
DQX
May 27, 2022K212268FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
FMD Co., Ltd., JP
DQX
Oct 12, 2004K042561TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
Fmd, LLC
LNS
May 2, 2003K030346TWINHEADS TH-101 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER
Fmd, LLC
LNS

Latest recalls

DateFirm and productCodeLinked 510(k)
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