Scientific Device Manufacturer, LLC
United StatesFDA applicant, unverified
- Devices
- 6
What Scientific Device Manufacturer, LLC makes
Scientific Device Manufacturer, LLC produces intrauterine pressure (IUP) transducers for monitoring uterine contractions, including both tip and proximal transmission types. Their portfolio also includes a safe-cath catheter, a Percuglide device for guided procedures, and a control syringe for precise fluid administration. Additional offerings are a tocodynamometer transducer for fetal monitoring and pressure stopcocks/manifolds for fluid management systems.
All listed devices fall under FDA Class II regulation and are authorised via the 510(k) pathway. The manufacturer’s products are registered in the FDA’s 510(k) clearance database. The company is based in the United States.
Catalogue
Iup - Tip Trans, Iup - Proxi Trans Ref K961290
Regimes: 510(k) Registry: 510(k)Safe-Cath Ref K960764
Regimes: 510(k) Registry: 510(k)Percuglide Ref K960917
Regimes: 510(k) Registry: 510(k)Control Syringe Ref K960430
Regimes: CE MDD 510(k) Registry: 510(k)Toco Transducer Ref K952579
Regimes: 510(k) Registry: 510(k)Pressure Stopcock/Manifold Ref K960431
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Scientific Device Manufacturer, LLC have in the registry?
The registry currently lists 6 devices for Scientific Device Manufacturer, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scientific Device Manufacturer, LLC's devices?
Among its 6 most recently registered devices, Scientific Device Manufacturer, LLC has devices listed in FDA 510(k) (6 devices).
What risk classes do Scientific Device Manufacturer, LLC's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Scientific Device Manufacturer, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Scientific Device Manufacturer, LLC in the registry?
The most recently registered devices listed for Scientific Device Manufacturer, LLC include IUP - TIP TRANS, IUP - PROXI TRANS, SAFE-CATH, PERCUGLIDE and CONTROL SYRINGE.