Biodex Medical Systems, Inc. is one of 21528 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Biodex Medical Systems, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336, SHARPS CONTAINER, MODEL 039-413, BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP
9
Total
8
Cleared
0
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.
510(k) submissions have been managed by Intertek Testing Services as regulatory consultant.
FDA 510(k) Regulatory Record - Biodex Medical Systems, Inc.
9 devices
Cleared
Feb 19, 2009
ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332,...
Radiology
13d
Cleared
Jan 25, 2007
SHARPS CONTAINER, MODEL 039-413
General Hospital
45d
Cleared
Nov 16, 1995
BIODEX SYSTEM 3 MODEL S3S-AP AND MODEL S3D-3AP
Physical Medicine
213d
Cleared
Apr 03, 1995
ULTRA-PRO ULTRASOUND SCANNING TABLE MODEL #056-650
Radiology
31d
Cleared
Mar 10, 1995
STABILITY SYSTEM (110V) MODEL 945-300
Physical Medicine
276d
Cleared
Dec 28, 1994
COMPEX 2
Physical Medicine
338d
Cleared
Sep 16, 1994
LOWER BODY CYCLES
Physical Medicine
330d
Cleared
Sep 16, 1994
SEMI-RECUMBENT CYCLES
Physical Medicine
325d
Cleared
Sep 16, 1994
UPPER BODY CYCLES (110 VOLT)/(220 VOLT)
Physical Medicine
302d