App Pharmaceuticals, LLC
Country not established
- Devices
- 1
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What App Pharmaceuticals, LLC makes
App Pharmaceuticals, LLC manufactures heparin lock flush solutions, including sterile, non-pyrogenic flushes for intravenous lines, available in various concentrations and package sizes for medical use.
These products are regulated as Class II medical devices under the FDA’s 510(k) clearance pathway and are listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 2 recalls initiated by App Pharmaceuticals, LLC, initiated on 2010-05-20. By recorded status: 2 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2010
- 20 May 2010 Z-1824-2012 Class II Terminated CGMP Deviations: Incomplete documentation associated with test results.
- 20 May 2010 Z-1825-2012 Class II Terminated CGMP Deviations: Incomplete documentation associated with test results.
Frequently asked questions
How many devices does App Pharmaceuticals, LLC have in the registry?
The registry currently lists 1 device for App Pharmaceuticals, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list App Pharmaceuticals, LLC's devices?
Among its 1 most recently registered device, App Pharmaceuticals, LLC has devices listed in FDA 510(k) (1 device).
What risk classes do App Pharmaceuticals, LLC's devices fall under?
Among its 1 most recently registered device, the classes recorded for App Pharmaceuticals, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for App Pharmaceuticals, LLC?
FDA recall records list 2 recalls initiated by App Pharmaceuticals, LLC, the most recent initiated on 20 May 2010. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from App Pharmaceuticals, LLC in the registry?
The most recently registered devices listed for App Pharmaceuticals, LLC include HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710.