Company ยท US
Biodex Medical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2009. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 19, 2009 | K090296 | ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 Biodex Medical Systems, Inc. | KPT |
| Jan 25, 2007 | K063666 | SHARPS CONTAINER, MODEL 039-413 Biodex Medical Systems, Inc. | MMK |
| Nov 16, 1995 | K951770 | BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP Biodex Medical Systems, Inc. | IKK |
| Apr 3, 1995 | K950981 | ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650 Biodex Medical Systems, Inc. | IXR |
| Mar 10, 1995 | K942694 | STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302 Biodex Medical Systems, Inc. | KHX |
| Dec 28, 1994 | K940301 | COMPEX 2 Biodex Medical Systems, Inc. | IPF |
| Sep 16, 1994 | K935520 | UPPER BODY CYCLES (110 VOLT)/(220 VOLT) Biodex Medical Systems, Inc. | BXB |
| Sep 16, 1994 | K935216 | SEMI-RECUMBENT CYCLES Biodex Medical Systems, Inc. | BXB |
| Sep 16, 1994 | K935061 | LOWER BODY CYCLES Biodex Medical Systems, Inc. | BXB |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 16, 2021 | Biodex Medical Systems, Inc. AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive
Model: 086-332 Terminated |
KPT | K090296 |
| Aug 16, 2021 | Biodex Medical Systems, Inc. Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive
Model: 086-330. Terminated |
KPT | K090296 |