MWT Materials, Inc.
Passaic, NJ, US
MWT Materials, Inc. appears in FDA device records in Passaic, NJ. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 11 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 11
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0673-2016 | Accusorb MRI MAC7030 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | When not used correctly, Accusorb MRI products may overheat and lead to patient injury. | Class II | Terminated | |
| Z-0672-2016 | Accusorb MRI MAC7010 Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | When not used correctly, Accusorb MRI products may overheat and lead to patient injury. | Class II | Terminated | |
| Z-0671-2016 | Accusorb MRI MAC7009 Part Number: MRI-09 MRI- Leg Wrap Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | When not used correctly, Accusorb MRI products may overheat and lead to patient injury. | Class II | Terminated | |
| Z-0670-2016 | Accusorb MRI MAC7006 Part Number: MRI-06 MRI-Large Torso Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | When not used correctly, Accusorb MRI products may overheat and lead to patient injury. | Class II | Terminated | |
| Z-0669-2016 | Accusorb MRI MAC7005 Part Number: MRI-05 Leg Wrap Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | When not used correctly, Accusorb MRI products may overheat and lead to patient injury. | Class II | Terminated | |
| Z-0668-2016 | Accusorb MRI MAC7003 Part Number: MRI-03 U (Upper) and MRI-03 L (Lower) Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | When not used correctly, Accusorb MRI products may overheat and lead to patient injury. | Class II | Terminated | |
| Z-0667-2016 | Accusorb MRI MAC7008 Part Number: MRI-08 MRI-Boot Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | When not used correctly, Accusorb MRI products may overheat and lead to patient injury. | Class II | Terminated | |
| Z-0666-2016 | Accusorb MRI MAC7007 Part Number: MRI-07 MRI-Breast Shield Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | When not used correctly, Accusorb MRI products may overheat and lead to patient injury. | Class II | Terminated | |
| Z-0665-2016 | Accusorb MRI MAC7004 Part Number: MRI-04 MRI-Poncho Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | When not used correctly, Accusorb MRI products may overheat and lead to patient injury. | Class II | Terminated | |
| Z-0664-2016 | Accusorb MRI MAC7002 Part Number: MRI-02 MRI-Arm Sleeve Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | When not used correctly, Accusorb MRI products may overheat and lead to patient injury. | Class II | Terminated | |
| Z-0663-2016 | Accusorb MRI MAC7001 Part Number: MRI-01 MRI-Large Blanket Various Sizes Product Usage: Radio frequency shielding blankets and body-part covers for the MRI environment. | When not used correctly, Accusorb MRI products may overheat and lead to patient injury. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain