Laurimed, LLC
United StatesFDA applicant, unverified
Laurimed, LLC is a medical device manufacturer, with 10 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) and 1 FDA recall as of 13 Nov 2026.
- Devices
- 10
- FDA recalls
- 1
Registry facts
- Registries
- FDA 510(k) 8
- FDA GUDID 2
- Device classes
- FDA Class II 10
- FDA recalls
- Identifiers
- DUNS 622446255
At a glance
Market reach
- United States
- FDA recalls
What Laurimed, LLC makes
Laurimed, LLC manufactures surgical handpieces and systems for ENT (ear, nose, and throat) procedures, including microdebriders and polyp removal tools. Their products include the PolypVac® system, designed for endoscopic sinus surgery, and microdebriders in 3.3 mm and 4.0 mm sizes for tissue removal. The company also provides spinal injection systems and percutaneous discectomy tools for minimally invasive spinal interventions.
These devices are classified as Class II under FDA regulations, requiring premarket notification (510(k)) or unique device identification (UDI) compliance. They are listed in the FDA’s 510(k) and UDI registries, adhering to U.S. medical device authorization requirements. The manufacturer operates from the United States.
Catalogue
- Registry: GUDID
- Registry: GUDID
Laurimed Spinal Injection System Ref K080140
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
PolypVac Microdebrider (3.3mm and 4.0mm) Ref K161101
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Laurimed Polypvac Microdebrider Ref K133133
Regimes: 510(k) Registry: 510(k)Percutaneous Discectomy System Ref K090815
Regimes: 510(k) Registry: 510(k)Spinal Injection System Ref K083909
Regimes: 510(k) Registry: 510(k)Laurimed Spinal Injection System Ref K091818
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 622446255
FDA recalls
FDA recall records list 1 recall initiated by Laurimed, LLC, initiated on 2014-04-07. By recorded status: 1 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.
2014
- 7 Apr 2014 Z-1527-2014 Class III Terminated The reciprocation mechanism in the PolypVac Microdebrider may turn off prematurely due to a component failure in the device handle.
Frequently asked questions
How many devices does Laurimed, LLC have in the registry?
The registry currently lists 10 devices for Laurimed, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Laurimed, LLC's devices?
Among its 10 most recently registered devices, Laurimed, LLC has devices listed in FDA 510(k) (8 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Laurimed, LLC's devices fall under?
Among its 10 most recently registered devices, the classes recorded for Laurimed, LLC's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Laurimed, LLC?
FDA recall records list 1 recall initiated by Laurimed, LLC, the most recent initiated on 7 Apr 2014. 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 Laurimed, LLC in the registry?
The most recently registered devices listed for Laurimed, LLC include PolypVac® 4.0mm Microdebrider, PolypVac® 3.3mm Microdebrider, LAURIMED SPINAL INJECTION SYSTEM and 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider.