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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 4 of 6

Device	Model / Reference	Registries	Class	Status
Surgical C Arm Table	058-875-10	FDA UDI	Class II	Unknown
Lead Lined	244-142	FDA UDI	Class I	Active
Pro-Tec Pet Syringe Shield	007-967	FDA UDI	Class I	Active
Surgical C Arm Table	058-840-10	FDA UDI	Class II	Unknown
Surgical C Arm Table	058-846-10	FDA UDI	Class II	Unknown
Gait Trainer 3	950-406	FDA UDI	Class I	Active
Sharps Container Shield	039-350	FDA UDI	Class I	Active
Gait Trainer 3	950-404	FDA UDI	Class I	Active
Pro-Tec III Syringe Shield	007-734	FDA UDI	Class I	Active
Pulmonex	132-503	FDA UDI	Class II	Active
Pro-Tec Pet Syringe Shield	007-980	FDA UDI	Class I	Active
Shielded Decay Drum	039-287	FDA UDI	Class I	Active
Pro-Tec Pet Syringe Shield	007-969	FDA UDI	Class I	Active
BETA, Syringe Shield	007-956	FDA UDI	Class I	Active
Aerotech I Radioaerosol Administration System	177-124	FDA UDI	Class II	Active
Pet Vial Pig	001-706	FDA UDI	Class I	Active
Lead Lined	244-141	FDA UDI	Class I	Active
Biostep 2, 100-240 VAC	950-240	FDA UDI	Class I	Active
Xenon Rebreathing System	132-774	FDA UDI	Class II	Active
Atomlab	187-601	FDA UDI	Class I	Active
Vasc Pro Table	058-732	FDA UDI	Class I	Unknown
Xenon Rebreathing System	132-692	FDA UDI	Class II	Active
Surgical C Arm Table	058-840	FDA UDI	Class II	Unknown
Zevalin	001-789	FDA UDI	Class I	Active
Atomlab 500 Dose Calibrator	086-330	FDA UDI	Class II	Active
Lead Lined	244-006	FDA UDI	Class I	Active
Gait Trainer 3	950-408	FDA UDI	Class I	Active
Lead Lined	244-152	FDA UDI	Class I	Active
Mobile Radiation Shield	042-522	FDA UDI	Class I	Active
Shipping System	001-921	FDA UDI	Class I	Active
Lead Lined	244-122	FDA UDI	Class I	Active
Brachytherapy Table	058-810	FDA UDI	Class II	Unknown
Vial Shield	053-806	FDA UDI	Class I	Active
High Density Lead Glass, Syringe Shield	007-652	FDA UDI	Class I	Active
Shielded Storage Container	050-200	FDA UDI	Class I	Active
Xenon Rebreathing System	132-771	FDA UDI	Class II	Active
Pet Unit Dose	001-785	FDA UDI	Class I	Active
Lead Lined	244-191	FDA UDI	Class I	Active
Lead Lined	244-181	FDA UDI	Class I	Active
Tabletop Shield	042-224	FDA UDI	Class I	Active
Echo / Vasc Pro Table	058-702	FDA UDI	Class I	Unknown
Urology C Arm Table	058-800	FDA UDI	Class II	Unknown
Pro-Tec III Syringe Shield	007-723	FDA UDI	Class I	Active
BETA, Syringe Shield	007-957	FDA UDI	Class I	Active
Pet / MR Pro-Tec, Syringe Shield	007-962	FDA UDI	Class I	Active
Venti-Scan Iv	177-090	FDA UDI	Class II	Active
Lead Lined	244-182	FDA UDI	Class I	Active
Lead Lined	244-161	FDA UDI	Class I	Active
Tabletop Shield	042-226	FDA UDI	Class I	Active
Xenon Rebreathing System	060-137	FDA UDI	Class II	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