Puritan Bennett Corp.
Country not established
- Devices
- 114
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Puritan Bennett Corp. makes
The company manufactures respiratory support devices, including proportional solenoid valves for ventilator control, portable liquid oxygen systems, and oxygen concentrators with integrated oxygen conservation features. It also produces nasal CPAP systems, diagnostic respiratory support platforms, microprocessor-controlled ventilators, manual resuscitators for infants, and patient monitoring devices for vital signs. Additional offerings include patient circuits for portable ventilators and standalone respiratory support systems.
These devices are regulated under the FDA’s 510(k) pathway, with most classified as Class I or Class II medical devices. The portfolio is listed in the FDA’s 510(k) clearance registry, and the company is based in the United States.
Catalogue
Search and filter all 114 devicesShowing 1-50 of 114
FDA recalls
FDA recall records list 2 recalls initiated by Puritan Bennett Corp., the earliest on 2005-04-20 and the most recent on 2006-08-31. By recorded status: 2 terminated. The reasons filed fall into these groups: manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 31 Aug 2006 Z-0444-2007 Unclassified (pre-2012) Terminated Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use.
Full distribution text
- 31 Aug 2006 Z-0444-2007 Unclassified (pre-2012) Terminated Directions for Use-Puritan Bennett has determined that a service interval should be defined for the device. The firm has also determined that an exhalation filter should be employed when the device is in use.
2005
- 20 Apr 2005 Z-1085-05 Unclassified (pre-2012) Terminated Manufacturing defect at contract manufacturer, employee error, poor training, improper inspection.
Frequently asked questions
How many devices does Puritan Bennett Corp. have in the registry?
The registry currently lists 114 devices for Puritan Bennett Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Puritan Bennett Corp.'s devices?
Among its 50 most recently registered devices, Puritan Bennett Corp. has devices listed in FDA 510(k) (50 devices).
What risk classes do Puritan Bennett Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Puritan Bennett Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Puritan Bennett Corp.?
FDA recall records list 2 recalls initiated by Puritan Bennett Corp., the most recent initiated on 2006-08-31. 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 Puritan Bennett Corp. in the registry?
The most recently registered devices listed for Puritan Bennett Corp. include PROPORTIONAL SOLENOID VALVE, PURITAN-BENNETT HELIOS PORTABLE LIQUID OXYGEN SYSTEM, PURITAN-BENNETT AERIS 590 OXYGEN CONCENTRATOR WITH OCI and COMPANION 318 NASAL CPAP DIAGNOSTICS SYSTEM.