Zoll Manufacturing Corp.
Zoll Manufacturing Corp. has 1 FDA recall, 6 inspections, 3 510(k) clearances and 1 compliance action on record.
- Latest recall
- Z-0353-2018 · Class II · Sep 12, 2017
- Latest inspection
- Feb 12, 2018 · NAI
- Latest 510(k)
- Dec 19, 2019
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Summary
- Recalls
- 1
- 510(k) Clearances
- 3
- Inspections
- 6
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0353-2018 | Class II | LifeVest Wearable Defibrillator Model 4000, Product Number 10A0988-A01. The LifeVest system is… | Sep 12, 2017 |
Recent FDA Inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Feb 12, 2018 | Pittsburgh, PA | Devices | No Action Indicated (NAI) | 3008642652 |
| Jul 15, 2016 | Pittsburgh, PA | Devices | No Action Indicated (NAI) | 3008642652 |
| Mar 9, 2015 | Pittsburgh, PA | Devices | Voluntary Action Indicated (VAI) | 3008642652 |
| Jun 20, 2014 | Pittsburgh, PA | Devices | Official Action Indicated (OAI) | 3008642652 |
| Jan 19, 2012 | Pittsburgh, PA | Devices | Voluntary Action Indicated (VAI) | 3008642652 |
| Mar 11, 2010 | Pittsburgh, PA | Devices | No Action Indicated (NAI) | 3008642652 |