Sigma
Country not established
- Devices
- 6
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Sigma makes
Sigma manufactures infusion pumps, including the SIGMA 7000-6000 INFUSION PUMPS and SIGMA 7000 models, as well as medical culture media products like MCDB-105 MED. M6395 and MCDB-110 MED. M6520, and a device called SMART ADJUSTER (SA201).
The company's products are listed in the FDA 510(k) registry and include Class I, Class II, and U devices. Sigma is based in the US.
Catalogue
Sigma 7000-6000 Infusion Pumps Ref K830038
Regimes: 510(k) Registry: 510(k)Sigma 7000 Ref K820038
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Smart Adjuster (SA201) Ref K962239
Regimes: 510(k) Registry: 510(k)Sigma 7000 And SIGMA70002 Ref K926191
Regimes: 510(k) Registry: 510(k)Mcdb-110 Med. M6520 W/L-Glutamine-25M M Herpes & Ref K851737
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Sigma, initiated on 2012-04-23. By recorded status: 1 terminated. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2012
- 23 Apr 2012 Z-2030-2012 Class III Terminated Sigma is a safety alert for the Master Drug Library (MDL) Editor software associated with the SIGMA Spectrum Infusion Pump System because it may result in a facility drug library that does not represent common clinical practices.
Frequently asked questions
How many devices does Sigma have in the registry?
The registry currently lists 6 devices for Sigma. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sigma's devices?
Among its 6 most recently registered devices, Sigma has devices listed in FDA 510(k) (6 devices).
What risk classes do Sigma's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Sigma's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Sigma?
FDA recall records list 1 recall initiated by Sigma, the most recent initiated on 23 Apr 2012. 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 Sigma in the registry?
The most recently registered devices listed for Sigma include SIGMA 7000-6000 INFUSION PUMPS, SIGMA 7000, MCDB-105 MED. M6395, W/L-GLUTAMINE, 25M M HERPES & and SMART ADJUSTER (SA201).