Splint, Extremity, Non-inflatable, External, Non-sterile
General, Plastic Surgery · 21 CFR 878.3910
Non-inflatable extremity splint; See product code fyh.
Recent MDR events
13 adverse event reports on file
- SECURESLEEVE, INFANTDec 5, 2025MalfunctionTidi Products Llc2182318-2025-00104
- SAGER EMERGENCY SPLINTSep 12, 2022MalfunctionSmiths Medical International, Ltd.3012307300-2022-18643
- FLENTSFeb 26, 2020InjuryApothecary Products Llc2183416-2020-00002
- EXOS SPLINTFeb 7, 2019MalfunctionDjo, LlcMW5083846
- SECURESLEEVE, INFANTJun 29, 2018InjuryPosey Products Llc2020362-2018-00048
- PROCAREMar 16, 2018InjuryDjo, Llc9616086-2018-00005
- PROCAREMar 8, 2018InjuryDjo, Llc9616086-2018-00003
- FOOT SPLINTSep 23, 2016InjuryDarcoMW5065035
- PEDI-WRAPSep 3, 2015InjuryMedi-kid Co.MW5056029
- E-THOTICMar 17, 2015InjuryFixes 4 Kids2921578-2015-00008
Event type breakdown
Recalls
1 recall events for this product code
Registered firms
165 firms currently registered for this product code
Foundation Wellness International Co., Ltd (fwil)
Binh Duong, VN
Tuper Medical Co., Ltd.
Dezhou City Shandong, CN
Chengdu Ruinuo Meijer Medical Instrument Co., Ltd.
Chengdu Sichuan, CN
Suzhou Sunmed Co., Ltd
SUZHOU CITY Jiangsu, CN
Dick Medical Supply
COLUMBUS, OH, US
Comfort Plus Corporation
New Taipei City, TW
Ossur Iceland Ehf.
REYKJAVIK, IS
Garware Fulflex Usa Inc. (previously Avcor Health Care Products, Inc.)
Fort Worth, TX, US
Suzhou Meccan Import And Export Corp.
Suzhou Jiangsu, CN
Heaven Healthcare Co., Ltd.
Shaoxing Zhejiang, CN
Safeguard Medical Technologies Ltd
Hereford Herefordshire, GB
Cc Hsing Company Limited
Xikou Township Chiayi, TW
Yoorim Corp.
EUMSEONG-GUN Chungbuk, KR
Immco Diagnostics, Inc.
Williamsville, NY, US
Gauke (hubei) Healthcare Co., Ltd
Huanggang City Hubei, CN
Vernon Area Rehabilitation Center, Inc. - Sauk Division
Reedsburg, WI, US
Bsn Medical Gmbh
Hamburg, DE
X-cen-tek Gmbh & Co. Kg
Wardenburg Lower Saxony, DE
Ffa, Llc Div Prostat First Aid
La Verne, CA, US
Yiwu Kebon Healthcare Co., Ltd.
Yiwu Zhejiang, CN
Becon Medical Ltd.
Batavia, IL, US
Dimension Ortho Inc.
Philadelphia, PA, US
Shanghai No. 2 Medical College Duhang Medical Equipment Factory
Shanghai, CN
Heitco, Inc.
Avon, OH, US
Gfa Production Inc
Clearwater, FL, US
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.