Biosphere Medical, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Biosphere Medical, Inc. - FDA 510(k) Cleared Devices
6
Total
6
Cleared
0
Denied
Biosphere Medical, Inc. has 6 FDA 510(k) cleared medical devices. Based in Rockland, US.
Historical record: 6 cleared submissions from 2001 to 2012. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Biosphere Medical, Inc. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Biosphere Medical, Inc.
6 devices
Cleared
Mar 08, 2012
QUADRASPHERE 30 TO 60
Neurology
72d
Cleared
Nov 07, 2006
HEPASPHERE MICROSPHERES
Neurology
403d
Cleared
Aug 09, 2006
EMBOCATH PLUS INFUSION MICROCATHETER, MODEL ECP-100 AND ECP-135
Cardiovascular
14d
Cleared
Jun 02, 2006
SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX
Cardiovascular
36d
Cleared
Nov 22, 2002
EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID...
Obstetrics & Gynecology
204d
Cleared
Jun 21, 2001
EMBOGOLD MICROSPHERE
Neurology
169d