Medical Device Manufacturer · US , Shirley , NY

Biodex Medical Systems, Inc. - FDA 510(k) Cleared Devices

9 submissions · 8 cleared · Since 1994

Total

Cleared

Denied

Biodex Medical Systems, Inc. has 8 FDA 510(k) cleared medical devices. Based in Shirley, US.

Historical record: 8 cleared submissions from 1994 to 2009. Primary specialty: Physical Medicine.

Browse the FDA 510(k) cleared devices submitted by Biodex Medical Systems, Inc. Filter by specialty or product code using the sidebar.

FDA 510(k) Regulatory Record - Biodex Medical Systems, Inc.

9 devices

1-9 of 9

Cleared Feb 19, 2009

ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332,...

K090296 · KPT

Radiology · 13d

Cleared Jan 25, 2007

SHARPS CONTAINER, MODEL 039-413

K063666 · MMK

General Hospital · 45d

Cleared Nov 16, 1995

BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP

K951770 · IKK

Physical Medicine · 213d

Cleared Apr 03, 1995

ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650

K950981 · IXR

Radiology · 31d

Cleared Mar 10, 1995

STABILITY SYSTEM (110V) MODEL 945-300

K942694 · KHX

Physical Medicine · 276d

Cleared Dec 28, 1994

COMPEX 2

K940301 · IPF

Physical Medicine · 338d

Cleared Sep 16, 1994

LOWER BODY CYCLES

K935061 · BXB

Physical Medicine · 330d

Cleared Sep 16, 1994

SEMI-RECUMBENT CYCLES

K935216 · BXB

Physical Medicine · 325d

Cleared Sep 16, 1994

UPPER BODY CYCLES (110 VOLT)/(220 VOLT)

K935520 · BXB

Physical Medicine · 302d

Biodex Medical Systems, Inc. - FDA 510(k) Cleared Devices

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