Haemacure Corp.
United StatesFDA applicant, unverified
- Devices
- 2
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Haemacure Corp. makes
Haemacure Corp. manufactures the Hemamyst Surgical Applicator System, Model H-AS01, which is a Class II medical device used for surgical applications.
The company is based in the US and its products are listed in the FDA 510(k) registry, indicating they are Class II devices that have been cleared for market through the 510(k) process.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Haemacure Corp., initiated on 2009-11-16. By recorded status: 1 terminated. The reasons filed fall into these groups: labeling or instructions for use, packaging and 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.
2009
- 16 Nov 2009 Z-1537-2012 Unclassified (pre-2012) Terminated This product has been recalled due to the lot number being different on the box and pouch. The lot number on the box label was incorrectly printed as 11144 instead of 111144. The pouch label referenced the correct lot number, 111144.
Frequently asked questions
How many devices does Haemacure Corp. have in the registry?
The registry currently lists 2 devices for Haemacure Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Haemacure Corp.'s devices?
Among its 2 most recently registered devices, Haemacure Corp. has devices listed in FDA 510(k) (2 devices).
What risk classes do Haemacure Corp.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Haemacure Corp.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Haemacure Corp.?
FDA recall records list 1 recall initiated by Haemacure Corp., the most recent initiated on 16 Nov 2009. 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 Haemacure Corp. in the registry?
The most recently registered devices listed for Haemacure Corp. include HEMAMYST SURGICAL APPLICATOR SYSTEM, MODEL H-AS01 and HAEMACURE HEMAMYST SURGICAL APPLICATOR SYSTEM H-AS01.