Needle, Acupuncture, Single Use
General Hospital · 21 CFR 880.5580
Recent MDR events
13 adverse event reports on file
- SEIRIN ACUPUNCTURE NEEDLEJul 11, 2025InjurySeirin Corporation3003135788-2025-00001
- SEIRIN J-TYPE ACUPUNCTURE NEEDLESFeb 4, 2025InjurySeirin Corporation1000120741-2025-00001
- SEIRIN ACUPUNCTURE NEEDLES NO3 (.20) X 30 MM J TYPEMay 28, 2024InjurySeirin CorporationMW5155470
- SEIRIN ACUPUNCTURE NEEDLE WITH GUIDE TUBEAug 2, 2023MalfunctionSeirin CorporationMW5120522
- NEEDLEApr 9, 2018InjuryUnkMW5076399
- ACUPUNCTURE (FILIFORM) NEEDLEJan 17, 2016InjuryMW5059517
- PREMIO 10 MOXA - SEDATELECJun 25, 2015InjurySedatelec8020802-2015-00001
- ACUGLIDEJun 4, 2014MalfunctionHelio Medical Supplies3975815
- ACUPUNCTURE NEEDLEMay 16, 2013InjuryMW5030237
- DBC SPRINGTEN 0.25X30Oct 30, 2008MalfunctionMW5008835
Event type breakdown
Most-reported manufacturers
Recalls
1 recall events for this product code
Registered firms
106 firms currently registered for this product code
Feeltech Co.,ltd.
Gunsan-si Jeonbuk, KR
Suzhou Hengxiang Imp. & Exp. Co., Ltd
SUZHOU Jiangsu, CN
Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd
XIANGCHENG DISTRICT SUZHOU CITY Jiangsu, CN
Wujiang City Cloud & Dragon Medical Device Co., Ltd
Suzhou Jiangsu, CN
Hansol Medical Co.
PAJU-SI Gyeonggi, KR
Jiangsu Zhiyu Medical Instrument Co., Ltd
West Taixing City Jiangsu, CN
American 3b Scientific
Tucker, GA, US
Hangzhou Goals Medical Technology Co., Ltd.
Hangzhou Zhejiang, CN
Dongbang Medical Co. Ltd.
BORYEONG-SI Chungnam, KR
Radia Industry Co., Ltd.
Takasaki Gunma, JP
Golden Needle Acupuncture Herbal & Medical Supply, Inc.
Fletcher, NC, US
Scientific Molding Corporation Ltd. Dba Smc Ltd.
Somerset, WI, US
Changchun Aik Medical Devices Co., Ltd.
Changchun Jilin, CN
Asia-med Gmbh
Pullach i.I. Bavaria, DE
Boen Healthcare Co., Ltd.
Suzhou Jiangsu, CN
Wiser Living
Seoul, KR
Red Coral Acupuncture Supplies
Melbourne Victoria, AU
Sedatelec
IRIGNY Rhone, FR
Eastern Currents Ltd
Vancouver British Columbia, CA
Tianjin Huahong Technology Co., Ltd.
Tianjin, CN
K.m.s Inc.
Cheonan-si Chungnam, KR
Tianjin Empecs Medical Device Co., Ltd.
TIANJIN, CN
Wuxi Jiajian Medical Instrument Co., Ltd
Wuxi Jiangsu, CN
Marian Monticello
MONTICELLO, IN, US
510(k) clearances
91 clearances for this product code
- Changchun Aik Medical Devices Co., Ltd.May 11, 2017
K162566 · AIK Sterile Acupuncture Needles for Single Use
- K.S. Choi CorporationAug 25, 2015
K142760 · Acuzone Acupuncture Needles, KSC DB Plus Acupuncture Needles
- Maanshan Bond Medical Instruments Co., Ltd.Jul 15, 2015
K150903 · EACU, ZAGU, JOCU, EAKU, BALANCE, TEMPO, ACUZONE, SMART, PRIME, ACUSTAR, ACUKING, Myotech Dry, Red Coral Premium, Red Coral J-Type, Red Coral Natural
- K.M.S., Inc.Jun 10, 2015
K142920 · KM Needles (Acupuncture Needle)
- Smc Intl., Inc.Aug 1, 2014
K141473 · SMC ACUPUNCTURE NEEDLE
- Asia-Med GmbH and CO KGDec 2, 2013
K132896 · CJ-TYPE: METAL HANDLE WITH GUIDE TUBE, PJ-TYPE: PLASTIC HANDLE WITH GUIDE TUBE, CB-TYPE: METAL HANDLE WITHOUT GUIDE TUBE
- Woojeon CompanyNov 4, 2011
K111392 · WOOJEON ACUPUNCTURE NEEDLE (=SERA ACUPUNCTURE NEEDLE)
- Biomate Medical Devices Technology Co., Ltd.Jun 20, 2011
K103061 · BIOMATE STERILE ACUPUNCTURE NEEDLE