Swemed Laboratories, Inc.
SwedenFDA applicant, unverified
- Devices
- 2
What Swemed Laboratories, Inc. makes
Swemed Laboratories, Inc. manufactures needle guides designed for ultrasound transducer compatibility and sterile needles used for amniocentesis and cyst puncture procedures.
These devices are classified under Class I and Class II regulations, with relevant submissions recorded in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
Needle Guide (For Ultrasound Transducers) Ref K862364
Regimes: 510(k) Registry: 510(k)Needle For Amniocentesis And Cyst Puncture Ref K862365
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Swemed Laboratories, Inc. have in the registry?
The registry currently lists 2 devices for Swemed Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Swemed Laboratories, Inc.'s devices?
Among its 2 most recently registered devices, Swemed Laboratories, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Swemed Laboratories, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Swemed Laboratories, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Swemed Laboratories, Inc. in the registry?
The most recently registered devices listed for Swemed Laboratories, Inc. include NEEDLE GUIDE (FOR ULTRASOUND TRANSDUCERS) and NEEDLE FOR AMNIOCENTESIS AND CYST PUNCTURE.