Splint, Extremity, Noninflatable, External, Sterile
General, Plastic Surgery · 21 CFR 878.3910
Recent MDR events
26 adverse event reports on file
- DALE BENDABLE ARMBOARDMar 22, 2021InjuryDale Medical Products, Inc.11541235
- DALE BENDABLE ARMBOARDNov 28, 2016InjuryDale Medical Products, Inc.1214422-2016-00001
- TEE PEEJun 4, 2008InjuryMedical SpecialtiesMW5007126
- COMFORT COOL THUMB CMC ABDUCTION SPLINTMay 30, 2008OtherNorth Coast Medical, Inc.2939821-2008-00001
- INSTY SPLINTNov 5, 2007MalfunctionApothecary Procucts, Inc.MW5004337
- DELTA-SPLINT SYNTH RL 4" X 15FTOct 22, 2003InjuryDepuy Ortho Tech- North Brunswick J&j Co.1818910-2003-00709
- DELTA-SPLINT SYNTH RL 4"X15FTOct 10, 2003MalfunctionDepuy-north Brunswick Casting Products Div.1818910-2003-00668
- DELTA-SPLINT SYNTH RL 4"X15FTAug 13, 2003InjuryDepuy-north Brunswick, Casting Products Division1818910-2003-00530
- DELTA SPLINT LONGUETTEAug 13, 2003InjuryDepuy-north Brunswick Casting Products Div.1818910-2003-00514
- EXTRA-FAST PLASTER(GL) 5INX5YDJun 5, 2003InjuryDepuy-north Brunswick/castings Products Division1818910-2003-00328
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
36 firms currently registered for this product code
Carwild Corp.
NEW LONDON, CT, US
Allmay International Limited
Tsimshatsui, HK
L Well Medtech Solutions Sdn. Bhd.
Nibong Tebal Pulau Pinang, MY
Zhejiang Rehan Medical Manufacturing Co., Ltd.
Jiaxing City Zhejiang, CN
Essity Distribution B.v.
GE Oostrum Fryslan, NL
Inro Medical Designs, Inc.
Dallas, TX, US
Arrow Internacional De Chihuahua S.a. De C.v.
CHIHUAHUA, MX
Changzhou Meiguan Care Products Technology Co.,ltd.
Changzhou Jiangsu, CN
Dale Medical Products, Inc.
New London, CT, US
Midwest Sterilization Corp.
JACKSON, MO, US
Intent Brands Llc
Falls Church, VA, US
Anertai Industrial Limited
Dongguan Guangdong, CN
Runlite S.a.
SOUMAGNE Liege, BE
Bsn Medical S.a. De C.v.
Reynosa Tamaulipas, MX
Icu Medical, Inc.
SAN CLEMENTE, CA, US
Medline Industries, Lp - Northfield
Northfield, IL, US
Advanced Product Solutions Inc.
Dothan, AL, US
Biosculptor Corporation
Hialeah, FL, US
Hangzhou Gspmed Medical Appliances Co., Ltd.
Hangzhou City Zhejiang, CN
Power Well Healthcare Technology Co., Ltd.
Changhua County, TW
Acme United Corp.
Rocky Mount, NC, US
Guardmed Healthcare Kh Co., Ltd.
Bati District Takeo, KH
Onlycare Inc
Denver, CO, US
Acme United Corp.
VANCOUVER, WA, US
Ear Buddies Ltd
Marlow Buckinghamshire, GB
510(k) clearances
8 clearances for this product code
- Trace Medical Equipment, Inc.May 19, 1993
K925145 · TRACE MODEL #'S 840, 841, 842, 845
- Johnson & Johnson Orthopaedics, Inc.Feb 1, 1993
K924984 · SPECIALIST(R) WALKER
- Kut-Guard, Inc.Sep 26, 1989
K895092 · KUT-SHIELD
- The Huxley Instrument Corp.Jul 2, 1985
K852558 · SPLINTS(ALL TYPE)
- Compression Splint Products, Inc.Oct 24, 1984
K843400 · HYDRO-SPLINT A SPONGE-COMPRESS DRESS
- Johnson & Johnson Professionals, Inc.Jul 2, 1982
K821693 · J & J DIP WATER ADDITIVE
- Johnson & Johnson Professionals, Inc.Jan 8, 1981
K802522 · DELTA-LITE CASTING TAPE & SPLINTS
- Orthopedic Systems, Inc.Jun 26, 1980
K801436 · ORTHOPEDIC LOWER EXTREMITY SUSPENSION