Sorenson Medical, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
- FDA recalls
- 6
At a glance
Market reach
- United States
- FDA recalls
What Sorenson Medical, Inc. makes
Sorenson Medical, Inc. makes infusion pumps, including continuous and intermittent ambulatory infusion pumps, and PCA and PCEA pumps for pain management. They also produce empty reservoir bags in various sizes.
The company's portfolio is classified as Class II devices and is listed in the FDA 510(k) registry. Sorenson Medical, Inc. is based in the US.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Ambit Continuous Ambulatory Infusion Pump Ref K033325
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Palm Pump Ref K002434
Regimes: 510(k) Registry: 510(k)Ambit Intermittent Ambulatory Infusion Pump Ref K033425
Regimes: 510(k) Registry: 510(k)Ambit Push & Play Ambulatory Infusion Pump Ref K052221
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 6 recalls initiated by Sorenson Medical, Inc., the earliest on 2002-11-25 and the most recent on 2006-10-10. By recorded status: 6 terminated. The reasons filed fall into these groups: sterility or contamination and packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2006
- 10 Oct 2006 Z-0185-2007 Unclassified (pre-2012) Terminated Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.
- 10 Oct 2006 Z-0186-2007 Unclassified (pre-2012) Terminated Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.
- 10 Oct 2006 Z-0187-2007 Unclassified (pre-2012) Terminated Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.
- 10 Oct 2006 Z-0188-2007 Unclassified (pre-2012) Terminated Sterile disposable cassette used with infusion pump may cause an under-infusion when used in a low flow rate therapy of less than 10 ml per hour.
- 3 May 2006 Z-1188-06 Unclassified (pre-2012) Terminated Intermittent Infusion pump may continually dispense medication under certain conditions.
2002
- 25 Nov 2002 Z-0496-03 Unclassified (pre-2012) Terminated Catheters have 2 unvalidated seal product configurations to produce a new hybrid seal that had not been verified or validated.
Frequently asked questions
How many devices does Sorenson Medical, Inc. have in the registry?
The registry currently lists 6 devices for Sorenson Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sorenson Medical, Inc.'s devices?
Among its 6 most recently registered devices, Sorenson Medical, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Sorenson Medical, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Sorenson Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Sorenson Medical, Inc.?
FDA recall records list 6 recalls initiated by Sorenson Medical, Inc., the most recent initiated on 10 Oct 2006. 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 Sorenson Medical, Inc. in the registry?
The most recently registered devices listed for Sorenson Medical, Inc. include 30 PUMP, CONTINUOUS LOW FLOW, 200 PUMP, INTERMITTENT WITH KVO OR CONTINUOUS, PCA PUMP, PAIN MANAGEMENT, PCEA PUMP, EPIDU, AMBIT CONTINUOUS AMBULATORY INFUSION PUMP, EMPTY RESERVOIR BAG, 50 ML, 100 ML, 250 ML, 500 ML, 1000M ML, 1500 ML, 2000 ML, 3000 ML and PALM PUMP.