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Biodex Medical Systems

United States·US-MF-000028834

Last updated June 8, 2026

Information

Country: United States
Address: 49, Natcon Drive, Shirley, United States
Website: simbex.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 6034482367
PRRC Contact: Amaris Ajamil
EUDAMED SRN: US-MF-000028834
FDA FEI Number: —
DUNS Number: —

Catalogue (271)

Page 1 of 6

Device	Model / Reference	Registries	Class	Status
Lead Lined	244-156	FDA UDI	Class I	Active
Pro-Tec II, Syringe Shield	007-901	FDA UDI	Class I	Active
Shielded Storage Container	050-250	FDA UDI	Class I	Active
Bar Phantom	243-955	FDA UDI	Class I	Active
Surgical C Arm Table	058-847	FDA UDI	Class II	Unknown
Gait Trainer 3	950-400	FDA UDI	Class I	Active
Xenon Rebreathing System	132-680	FDA UDI	Class II	Active
Pro-Tec IV Syringe Shield	007-680	FDA UDI	Class I	Active
Bar Phantom	243-800	FDA UDI	Class I	Active
Lead Lined	244-205	FDA UDI	Class I	Active
Xenon Rebreathing System	132-699	FDA UDI	Class II	Active
High Density Lead Glass Vial Shield	001-075	FDA UDI	Class I	Active
MJS System 3 Upgrade	850-822	FDA UDI	Class II	Unknown
Tabletop Shield	042-228	FDA UDI	Class I	Active
Vial Shield	053-610	FDA UDI	Class I	Active
Brachytherapy Table	058-815	FDA UDI	Class II	Unknown
Gait Trainer 3	950-405	FDA UDI	Class I	Active
Lead Lined	244-008	FDA UDI	Class I	Active
Lead Lined	244-130	FDA UDI	Class I	Active
Xenon Rebreathing System	132-684	FDA UDI	Class II	Active
Sound Pro Table	058-715	FDA UDI	Class I	Unknown
Shielded Decay Drum	039-289	FDA UDI	Class I	Active
Pro-Tec II, Syringe Shield	007-801	FDA UDI	Class I	Active
Gait Trainer 3	950-402	FDA UDI	Class I	Active
Clear Lead Barrier	042-580	FDA UDI	Class I	Unknown
3D Imaging C-Arm Table	058-820	FDA UDI	Class II	Unknown
Neck Phantom	043-365	FDA UDI	Class I	Active
High Density Lead Glass, Syringe Shield	007-620	FDA UDI	Class I	Active
Dose Drawing, Syringe Shield	007-693	FDA UDI	Class I	Active
Stand Dose Prep	042-455	FDA UDI	Class I	Active
Echocardiography Table	058-706	FDA UDI	Class I	Unknown
Mobile Radiation Shield	042-519	FDA UDI	Class I	Active
Surgical C Arm Table	058-875	FDA UDI	Class II	Unknown
Lead Lined	244-146	FDA UDI	Class I	Active
Pro-Tec Pet Syringe Shield	007-973	FDA UDI	Class I	Active
Shipping System	001-950	FDA UDI	Class I	Active
Xenon Rebreathing System	132-691	FDA UDI	Class II	Active
Shielded Decay Drum	039-288	FDA UDI	Class I	Active
Shielded Syringe Carriers	001-182	FDA UDI	Class I	Active
Bar Phantom	243-987	FDA UDI	Class I	Active
Pro-Tec II Syringe Shield	007-800	FDA UDI	Class I	Active
Pet Gaard Lock, Syringe Shield	007-718	FDA UDI	Class I	Active
Lead Lined	244-157	FDA UDI	Class I	Active
Pet Shipping System	001-739	FDA UDI	Class I	Active
Pet Shipping System	001-794	FDA UDI	Class I	Active
Dose Drawing, Syringe Shield	007-665	FDA UDI	Class I	Active
Venti-Scan	177-092	FDA UDI	Class II	Active
Bar Phantom	243-816	FDA UDI	Class I	Active
Tabletop Shield	042-227	FDA UDI	Class I	Active
Dose Drawing, Syringe Shield	007-663	FDA UDI	Class I	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (2)

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