Sophysa SA is one of 4724 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Sophysa SA - FDA 510(k) Cleared Devices
9
Total
9
Cleared
0
Denied
Sophysa SA has 9 FDA 510(k) cleared medical devices. Based in Wellesley, US.
Historical record: 9 cleared submissions from 2000 to 2017. Primary specialty: Neurology.
Browse the FDA 510(k) cleared devices submitted by Sophysa SA Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Sophysa SA
9 devices
Cleared
Apr 17, 2017
Pressio 2 ICP Monitoring System
Neurology
262d
Cleared
Apr 02, 2015
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM/POLARIS ADJUSTABLE VALVE WITH SIPHONX
Neurology
325d
Cleared
Jan 22, 2010
SIPHONX GRAVITATIONAL ANTISIPHON DEVICE
Neurology
262d
Cleared
Aug 11, 2009
POLARIS PRESSURE ADJUSTABLE VALVE, MODELS SPV, SPVA, SPVB, SPV-140, SPV-300,...
Neurology
182d
Cleared
Jul 05, 2007
PRESSIO ICP MONITORING SYSTEM
Neurology
307d
Cleared
Dec 14, 2004
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400
Neurology
92d
Cleared
Feb 26, 2004
POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB
Neurology
325d
Cleared
Mar 27, 2002
SOPHY PRESSURE ADJUSTABLE VALVE SYSTEM MODEL SM8
Neurology
159d
Cleared
Sep 21, 2000
SOPHY SU8 PRESSURE ADJUSTABLE VALVE
Neurology
426d