Panels › Physical Medicine › Product code ILH · Class 1

Splint, Hand, And Components

Regulation 890.3475

0510(k)s in 12 months (36 all time)

0recalls in 12 months (1 all time)

0recalls that name a 510(k)

Top companies in ILH

Company	510(k)s	Recalls
Fred Sammons, Inc.	21	0
Conco Medical Co.	5	0
Maddak, Inc.	2	0
Warm & Form, Orthopedic Materials	2	0
Alimed, Inc.	1	0
Biomet, Inc.	1	0
Depuy, Inc.	1	0
North Coast Medical Inc	0	1
Orthopedic Systems, Inc.	1	0
Secol Co.	1	0

Date	Firm and product	Code	Linked 510(k)
Oct 19, 2023	North Coast Medical Inc Gladiator, Wrist & Thumb Orthosis, Part Numbers: NC86650 (Small/Left), NC86651 (Small/Right), NC86652 (Medium/Left), NC86653 (Medium/Right), NC86654 (Large/Left), NC86655 (Large/Right), NC86656 (X-La Open, Classified	ILH	None listed

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