Hygia Health Services, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 14
- Inspections
- 3
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K100523 | ADULT CEREBRAL-SOMATIC OXIMETRY SENSOR, PEDIATRIC CEREBRAL-SOMATIC OXIMETRY SENSOR MODEL HHS-SAFB-SM | May 4, 2010 |
| K090074 | HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS | April 22, 2009 |
| K080424 | HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861 | May 28, 2008 |
| K053575 | HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS | February 15, 2006 |
| K041867 | HYGIA HEALTH SERVICES REPROCESSED OXIMAX SENSORS MODEL # HHS-MAX-A, HHS-MAX-AL, HHS-MAX-N | September 10, 2004 |
| K032821 | HYGIA HEALTH SERVICES REPROCESSED BLOOD PRESSURE CUFF | December 5, 2003 |
| K012715 | HYGIA HEALTH SERVICES REPROCESSED NELLCOT D-25 OXISENSOR II | August 1, 2003 |
| K021509 | HYGIA HEALTH SERVICES REPROCESSED NOVAMEDIX IMPAB MODELS 5065, 5075, 5087, 5089 | December 24, 2002 |
| K012650 | HYGIA HEALTH SERVICES REPROCESSED NUTECH FOOT WRAP | April 12, 2002 |
| K012657 | HYGIA HEALTH SERVICES REPROCESSED NUTECH CALF WRAP | April 12, 2002 |
| K012651 | HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FOOT WRAP MODELS FG 100, FG 200 | April 12, 2002 |
| K012654 | HYGIA HEALTH SERVICES REPROCESSED HUNTLEIGH FLOWTRON DVT SLEEVE MODELS DVT10, DVT 20, DVT 30, DVT 40 | April 12, 2002 |
| K012956 | HYGIA HEALTH SERVICES REPROCESSED NU TECH COMBO, MODEL LEFT LIMB AND RIGHT LIMB | April 11, 2002 |
| K012417 | HYGIA HEALTH SERVICE REPROCESSED KENDALL SCD SLEEVE, MODELS # 5329, 5330, 5345, 5480 | April 8, 2002 |