Shippert Medical Technologies
FDA Regulatory Profile
Shippert Medical Technologies appears in FDA public data with 15 recalls, 13 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1335-2019, Class II) was initiated on February 2, 2018. Its most recent 510(k) clearance was granted on August 6, 2010.
Summary
- Total Recalls
- 15
- 510(k) Clearances
- 13
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1335-2019 | Class II | Tissu-Trans MEGA 1500, Catalog 3-TT-MEGA 1500, sterile, disposable, one-patient use. The firm name | February 2, 2018 |
| Z-1336-2019 | Class II | Tissu-Trans Syringe Fill 360, Catalog 3-TT-SFILL 360, sterile, disposable, one-patient use. The fir | February 2, 2018 |
| Z-1331-2019 | Class II | Tissu-Trans FILTRON 250, Catalog 3-TT-FILTRON 250, sterile, disposable, one-patient use. The firm n | February 2, 2018 |
| Z-1332-2019 | Class II | Tissu-Trans FILTRON 500, Catalog 3-TT-FILTRON 500, sterile, disposable, one-patient use. The firm n | February 2, 2018 |
| Z-1334-2019 | Class II | Tissu-Trans FILTRON 2000, Catalog 3-TT-FILTRON 2000, sterile, disposable, one-patient use. The firm | February 2, 2018 |
| Z-1333-2019 | Class II | Tissu-Trans FILTRON 1000, Catalog 3-TT-FILTRON 1000, sterile, disposable, one-patient use. The firm | February 2, 2018 |
| Z-1330-2019 | Class II | Tissu-Trans FILTRON 100, Catalog 3-TT-FILTRON 100, sterile, disposable, one-patient use. The firm n | February 2, 2018 |
| Z-0170-2018 | Class II | Tissu-Trans Filtron 1000 Catalog Number 3-TT-FILTRON 1000. Used for fat transfer and liposuction. | October 20, 2017 |
| Z-3064-2017 | Class II | Tissu-Trans Filtron 2000, 3-TT-FILTRON 2000. Product Usage: Intended for fat transfer and liposu | June 1, 2017 |
| Z-3066-2017 | Class II | Tissu-Trans SFILL 360, 3-TT-SFILL 360. Product Usage: Intended for fat transfer and liposuction. | June 1, 2017 |
| Z-3062-2017 | Class II | Tissu-Trans Filtron 500, 3-TT-FILTRON 500. Product Usage: Intended for fat transfer and liposuct | June 1, 2017 |
| Z-3065-2017 | Class II | Tissu-Trans MEGA 1500, 3-TT-MEGA 1500. Product Usage: Intended for fat transfer and liposuction. | June 1, 2017 |
| Z-3063-2017 | Class II | Tissu-Trans Filtron 1000, 3-TT-FILTRON 1000. Product Usage: Intended for fat transfer and liposu | June 1, 2017 |
| Z-3060-2017 | Class II | Tissu-Trans Filtron 100, 3-TT-FILTRON 100. Product Usage: Intended for fat transfer and liposu | June 1, 2017 |
| Z-3061-2017 | Class II | Tissu-Trans Filtron 250, 3-TT-FILTRON 250. Product Usage: Intended for fat transfer and liposuctio | June 1, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K102117 | TISSU TRANS FILTRON SYRINGE FILL | August 6, 2010 |
| K092482 | TISSU TRANS FILTRON, MODELS 3-TT-FILTRON 2000-500 | December 4, 2009 |
| K092022 | TISSU TRANS HARVEST TUBING | August 17, 2009 |
| K050797 | TISSU-TRANS | July 13, 2005 |
| K964855 | EXPANDACELL EYE SPEAR, EYE WICK, WICK DRAIN AND CORNEAL SHIELD | March 4, 1997 |
| K964334 | EXPANDACELL ANTI-FOG INSTRUMENT WIPE (WITH ALCOHOL)/(WITHOUT) | December 9, 1996 |
| K963704 | MUSCLE WAND, A DEVICE FOR DEEP PRESSURE MUSCLE MASSAGE | November 26, 1996 |
| K962133 | EXPANDACELL INJECTO-PAK | August 1, 1996 |
| K960621 | EXPANDACELL INSTRUMENT WIPE | April 1, 1996 |
| K960228 | EXPANDACELL INJECTO-PAK NASAL PACK | February 27, 1996 |
| K955593 | EXPANDACELL ANATOMICAL POSTERIOR NASAL PACK W/& WITHOUT AIRWAY | December 22, 1995 |
| K954845 | EXPANDACELL INJECTO-PAK NASAL PACK | November 27, 1995 |
| K950024 | EXPANDACELL NASAL PACK WITH AIRWAY | February 17, 1995 |