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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 2 of 6

Device	Model / Reference	Registries	Class	Status
Reactive Step Trainer 115V	950-600	FDA UDI	Class I	Active
Sound Pro Table	058-710	FDA UDI	Class I	Unknown
Bacterial Filter	132-750	FDA UDI	Class II	Active
Shielded Syringe Carrier	001-180	FDA UDI	Class I	Active
MRI Stretcher	240-100	FDA UDI	Class II	Unknown
Pro-Tec Pet Syringe Shield	007-966	FDA UDI	Class I	Active
Atomlab Dose Calibrator	086-335	FDA UDI	Class II	Active
High Density Lead Glass, Syringe Shield	007-635	FDA UDI	Class I	Active
Pro-Tec III Syringe Shield	007-735	FDA UDI	Class I	Active
Shipping System	001-882	FDA UDI	Class I	Active
Aerotech I Radioaerosol Administration System	177-324	FDA UDI	Class II	Active
Echo Pro Table	058-705	FDA UDI	Class I	Unknown
Pro-Tec Pig	001-280	FDA UDI	Class I	Active
Biodex	950-148	FDA UDI	Class I	Active
Dose Drawing, Syringe Shield	007-695	FDA UDI	Class I	Active
Lead Lined	244-132	FDA UDI	Class I	Active
Echocardiography Table	058-701	FDA UDI	Class I	Unknown
Pet Dose Drawing Syringe Shield	007-984	FDA UDI	Class I	Active
Clear Lead Barrier	042-582	FDA UDI	Class I	Unknown
Echo / Vasc Pro Table	058-707	FDA UDI	Class I	Unknown
Shielded Syringe Carrier	001-179	FDA UDI	Class I	Active
Pet Vial Shield	001-855	FDA UDI	Class I	Active
Urology C Arm Table	058-805	FDA UDI	Class II	Unknown
Pro-Tec Pet Syringe Shield	007-983	FDA UDI	Class I	Active
Pro-Tec Pet Syringe Shield	007-975	FDA UDI	Class I	Active
Syringe Shield Holder	009-205	FDA UDI	Class I	Active
Bar Phantom	243-985	FDA UDI	Class I	Active
Pet / MR Pro-Tec, Syringe Shield	007-961	FDA UDI	Class I	Active
Ultra Pro Table	058-725	FDA UDI	Class I	Unknown
BETA, Syringe Shield	007-958	FDA UDI	Class I	Active
Lead Lined	244-004	FDA UDI	Class I	Active
Venti-Scan Iv	177-075	FDA UDI	Class II	Active
Biodex	950-146	FDA UDI	Class I	Active
Surgical C Arm Table	058-870	FDA UDI	Class II	Unknown
Surgical C Arm Table	058-845-10	FDA UDI	Class II	Unknown
Sit2Stand	950-560	FDA UDI	Class I	Active
Lead Lined	244-140	FDA UDI	Class I	Active
Dose Drawing, Syringe Shield	007-661	FDA UDI	Class I	Active
Air Cushioned Face Mask	132-685	FDA UDI	Class II	Active
Lead Lined	244-170	FDA UDI	Class I	Active
Air Cushioned Face Mask	132-698	FDA UDI	Class II	Active
Lead Lined	244-007	FDA UDI	Class I	Active
Balance Sd	950-444	FDA UDI	Class I	Active
Lead Lined	244-172	FDA UDI	Class I	Active
Pro-Tec Pet Syringe Shield	007-990	FDA UDI	Class I	Active
Xenon Rebreathing System	132-690	FDA UDI	Class II	Active
Xenon Rebreathing System	060-133	FDA UDI	Class II	Active
Pet Gaard Lock Syringe Shield	007-717	FDA UDI	Class I	Active
Shielded Syringe Carriers	001-181	FDA UDI	Class I	Active
Lead Lined	244-111	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