Quali-Med, Inc.
Country not established FDA
- Devices
- 9
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Quali-Med, Inc. makes
Quali-Med, Inc. manufactures single-use medical accessories, including blood vessel connectors for surgical procedures, disposable operating room drapes, and customizable procedure kits for various medical applications. Their portfolio also includes contact lenses (hydrophilic, daily wear, clear and tinted), PAP smear collection kits, and reusable quartz and titanium rods for medical devices. Additional products encompass standard and custom basin kits for surgical use and a disposable surgical mirror.
The company’s devices are classified under FDA Class II, requiring premarket notification (510(k)) clearance. These products are listed in the FDA’s 510(k) registry, reflecting their regulatory status in the United States. The manufacturer is based in the US.
Catalogue
Blood Vessel Connector Ref K871408
510(k) 510(k)Quali-Med's Operating Room Drapes Ref K862172
510(k) 510(k)Disposable Mirror Ref K862972
510(k) 510(k)- 510(k) 510(k)
- 510(k) 510(k)
Standard Basin Kit Custom Basin Kit Ref K862241
510(k) 510(k)Quartz Rods Titanium Rods Ref K862472
510(k) 510(k)Pap Smear Kit Ref K862242
510(k) 510(k)Custom Procedure Kit (Various Sub-Titles) Ref K861198
510(k) 510(k)
FDA establishments
- Qualimed SRL Gallarate Varese · IT FEI 3011553378
Frequently asked questions
How many devices does Quali-Med, Inc. have in the registry?
The registry currently lists 9 devices for Quali-Med, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Quali-Med, Inc.'s devices?
Among its 9 most recently registered devices, Quali-Med, Inc. has devices listed in FDA 510(k) (9 devices).
What risk classes do Quali-Med, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Quali-Med, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Quali-Med, Inc. in the registry?
The most recently registered devices listed for Quali-Med, Inc. include BLOOD VESSEL CONNECTOR, QUALI-MED'S OPERATING ROOM DRAPES, DISPOSABLE MIRROR and Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted).
Which FDA establishments are linked to Quali-Med, Inc.?
1 FDA establishment is linked to Quali-Med, Inc. in the registry; they are listed on the company page.