FDA Device Intelligence
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Joint, Ankle, External Brace

FDA product code ITW · Class 1 · Physical Medicine

2,114
Registered devices
70
Adverse events
3
Recalls
1
510(k) clearances

Devices with this code

DONJOY PERFORMANCE — DJO, LLCMEDI — MEDI MANUFACTURING, INC.F8X LACER ANKLE SUPPORT W/STAYS XS — Bird & Cronin, LLCBMI — Blake Manufacturing, Inc.TruCompress — VIVE HEALTH LLCANKLIZER II LOW-TOP FIXED MD — Bird & Cronin, LLCASO Ankle Stabilizer — MEDICAL SPECIALTIES INCORPORATEDCoreTech — VIVE HEALTH LLCDeRoyal — DEROYAL INDUSTRIES, INC.ANKLE STABILIZER SPRINT GREEN TRNR — Bird & Cronin, LLCDONJOY PERFORMANCE — DJO, LLCDeRoyal — DEROYAL INDUSTRIES, INC.ComfyHealth — Comfy Health Group Co., Ltd.CoreTech — VIVE HEALTH LLCF8X LACER ANKLE W/STAYS XL — Hausmann Enterprises, LLCDeRoyal — DEROYAL INDUSTRIES, INC.CoreTech — VIVE HEALTH LLCPUSH — Nea International B.V.ANKLIZER II - FIXED XL — Bird & Cronin, LLCANKLE STABILZIER SPRINT BLUE TRNR — Bird & Cronin, LLCANKLIZER WALKER FIXED LOW PROFILE XS — Bird & Cronin, LLCMEDI — MEDI MANUFACTURING, INC.EVO w/ Hinge Ankle Stabilizer — MEDICAL SPECIALTIES INCORPORATEDELASTIC ANKLE SUPPORT LG — Hausmann Enterprises, LLC

Recent recalls

DateFirmReason
2016-02-24Ossur H / FOssur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound
2016-02-24Ossur H / FOssur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound
2015-04-13United Surgical AssociatesThe product does not bear the caution label regarding latex content. Potential for Allergic skin reaction

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.