Biodex Medical Systems, Inc.
Biodex Medical Systems, Inc. holds FDA 510(k) medical device clearances, first cleared 1994, most recent 2009, with 2 FDA device recalls on record.
Top product codes for Biodex Medical Systems, Inc.
FDA recalls by Biodex Medical Systems, Inc.
- Z-2580-2021 — Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
- Z-2581-2021 — AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Biodex Medical Systems, Inc.
- K090296 — ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336
- K063666 — SHARPS CONTAINER, MODEL 039-413
- K951770 — BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP
- K950981 — ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650
- K942694 — STABILITY SYSTEM (110V) MODEL 945-300; STABILITY SYSTEM (220V) MODEL #945-302
- K940301 — COMPEX 2
- K935061 — LOWER BODY CYCLES
- K935216 — SEMI-RECUMBENT CYCLES
- K935520 — UPPER BODY CYCLES (110 VOLT)/(220 VOLT)
Data sourced from openFDA. This site is unofficial and independent of the FDA.