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Orthosis, Cervical
FDA product code IQK · Class 1 · Physical Medicine
1,038
Registered devices
100
Adverse events
6
Recalls
27
510(k) clearances
Devices with this code
CERVMAX® — PMT CORPORATIONDeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.CERVMAX® — PMT CORPORATIONWELLBRACE — PANTYMED S.A.Cervical Collar — Dynarex CorporationDeRoyal — DEROYAL INDUSTRIES, INC.WELLBRACE — PANTYMED S.A.CERVMAX® — PMT CORPORATIONTPC COLLAR W/TRACH 5.25" XLG — Bird & Cronin, LLCN/A — TETRA MEDICAL SUPPLY CORP.Immobilization Kit, with — Ambu A/SDeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.CERVMAX® — PMT CORPORATIONDeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.CERVMAX® — PMT CORPORATIONDeRoyal — DEROYAL INDUSTRIES, INC.SERP CERV COLLAR SOFT DENS XL — Bird & Cronin, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-20 | Ossur H / F | Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar panel can occasionally exhibit poor adhesion, which may lead to |
| 2021-11-09 | Ossur Americas | Instructions for use were updated to include additional information to facilitate the selection and use of the collar device. |
| 2021-06-01 | Ossur Americas | Due to insufficient column strength of the racks for all load conditions, racks associated with height adjustment functionality have been observed deforming, wh |
| 2016-02-24 | Ossur H / F | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound |
| 2016-02-24 | Ossur H / F | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound |
| 2016-02-24 | Ossur H / F | Ossur Americas is recalling , Knee Shield / Patella Cup, Knee Undersleeve Gray, NecLoc Extrication Collar, Rebound Cartilage, Rebound Cartilage Custom, Rebound |
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