Hygia Health Services, Inc. - FDA 510(k) Cleared Devices
Recent clearances: ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM, HHS-SPFB-USA, HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS, HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Hygia Health Services, Inc. Cardiovascular ✕
11 devices
Cleared
May 04, 2010
ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY...
Cardiovascular
69d
Cleared
Apr 22, 2009
HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS
Cardiovascular
100d
Cleared
Feb 15, 2006
HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS
Cardiovascular
55d
Cleared
Dec 05, 2003
HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF
Cardiovascular
91d
Cleared
Dec 24, 2002
HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089
Cardiovascular
229d
Cleared
Apr 12, 2002
HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP
Cardiovascular
242d
Cleared
Apr 12, 2002
HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200
Cardiovascular
242d
Cleared
Apr 12, 2002
HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10,...
Cardiovascular
242d
Cleared
Apr 12, 2002
HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP
Cardiovascular
242d
Cleared
Apr 11, 2002
HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB
Cardiovascular
219d
Cleared
Apr 08, 2002
HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330,...
Cardiovascular
252d