Biodex Medical Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 9
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2580-2021 | Class II | Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330. | August 16, 2021 |
| Z-2581-2021 | Class II | AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332 | August 16, 2021 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K090296 | ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 | February 19, 2009 |
| K063666 | SHARPS CONTAINER, MODEL 039-413 | January 25, 2007 |
| K951770 | BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP | November 16, 1995 |
| K950981 | ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 | April 3, 1995 |
| K942694 | STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 | March 10, 1995 |
| K940301 | COMPEX 2 | December 28, 1994 |
| K935216 | SEMI-RECUMBENT CYCLES | September 16, 1994 |
| K935061 | LOWER BODY CYCLES | September 16, 1994 |
| K935520 | UPPER BODY CYCLES (110 VOLT)/(220 VOLT) | September 16, 1994 |