Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Biodex Medical Systems with 9 510(k) clearances and 2 device recalls. The most recent is a device recall dated Aug 16, 2021: Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 08….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Aug 16, 2021 | Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.Class II · When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting | Device recalls |
| Aug 16, 2021 | AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332Class II · When deleting a previously entered custom isotope, the software deletes the isotope, but not the associated dial setting | Device recalls |
| Feb 19, 2009 | ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336K090296 · KPT | 510(k) clearances |
| Jan 25, 2007 | SHARPS CONTAINER, MODEL 039-413K063666 · MMK | 510(k) clearances |
| Nov 16, 1995 | BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3APK951770 · IKK | 510(k) clearances |
| Apr 3, 1995 | ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650K950981 · IXR | 510(k) clearances |
| Mar 10, 1995 | STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302K942694 · KHX | 510(k) clearances |
| Dec 28, 1994 | COMPEX 2K940301 · IPF | 510(k) clearances |
| Sep 16, 1994 | UPPER BODY CYCLES (110 VOLT)/(220 VOLT)K935520 · BXB | 510(k) clearances |
| Sep 16, 1994 | SEMI-RECUMBENT CYCLESK935216 · BXB | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
