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Biodex Medical Systems

United States·US-MF-000028834

Last updated June 8, 2026

Information

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Device	Model / Reference	Registries	Class	Status
Ultrasound able	058-726	FDA UDI	Class I	Unknown
Lead Lined	244-207	FDA UDI	Class I	Active
Upper Body Cycles (110 Volt)/(220 Volt)	K935520	FDA 510(k)	Class I	Active
Semi-Recumbent Cycles	K935216	FDA 510(k)	Class I	Active
Ultra-Pro Ultrasound Scanning Table Model #056-650	K950981	FDA 510(k)	Class II	Active
Biodex System 3 Model S3s-Ap And Model S3d-3ap	K951770	FDA 510(k)	Class II	Active
Lower Body Cycles	K935061	FDA 510(k)	Class I	Active
Stability System (110v) Model 945-300; Stability System (220v) Model #945-302	K942694	FDA 510(k)	Class I	Active
Sharps Container, Model 039-413	K063666	FDA 510(k)	Class II	Active
Compex 2	K940301	FDA 510(k)	Class II	Active
Atomlab 400 And Atomlab 500 Dose Calibrators, Models 086-330, -331, -332, -335 And -336	K090296	FDA 510(k)	Class II	Active
System 4 Pro	850-000	EUDAMEDFDA UDI	Class IIa	Active
Gait Trainer Iii, 230v	950-401	EUDAMEDFDA UDI	Class I	Active
Gt Iii, 230v, W/Ger Hndrls	950-407	EUDAMEDFDA UDI	Class I	Active
Vibrotactile Belt Kit	950-430	EUDAMEDFDA UDI	Class I	Active
System 4 Quick Set	840-000	EUDAMEDFDA UDI	Class IIa	Active
Gt Iii, 230v, W/Extd Hndrls	950-403	EUDAMEDFDA UDI	Class I	Active
NxSTEP UNWEIGHING SYSTEM	950-485	EUDAMEDFDA UDI	Class I	Active
NxSTEP UNWEIGHING SYSTEM w/o HARNESS	950-484	EUDAMEDFDA UDI	Class I	Active
Balance System Sd 230v	950-441	EUDAMEDFDA UDI	Class I	Active
System 4 MVP	852-000	EUDAMEDFDA UDI	Class IIa	Active

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Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Aug 16, 2021	Z-2581-2021	—	terminated	When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration
Aug 16, 2021	Z-2580-2021	—	terminated	When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may then have incorrect dial settings and may lead to an incorrect dose measurement and/or misadministration