Smiths Industries Medical Systems, Inc.
United StatesFDA applicant, unverified
- Devices
- 24
What Smiths Industries Medical Systems, Inc. makes
Smiths Industries Medical Systems, Inc. manufactures percutaneous tracheostomy kits, including fenestrated flexible tracheostomy tubes and adjustable flange tracheostomy tubes, as well as regional anesthesia trays. Their portfolio includes arterial blood sampling syringes (Pro-Vent, Pulsator, and Line Draw) and a SIMS CPAP system for respiratory support. Sharpsafe catheter devices and Wallace IV cannulas are also part of their product line, alongside epidural catheters (Concord/Portex).
The company’s devices are regulated under FDA classifications, including Class I, Class II, and Class III, with submissions recorded in the 510(k) and PMA registries. Their products are listed under U.S. FDA oversight, and the manufacturer operates from the United States.
Catalogue
Search and filter all 24 devicesFrequently asked questions
How many devices does Smiths Industries Medical Systems, Inc. have in the registry?
The registry currently lists 24 devices for Smiths Industries Medical Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Smiths Industries Medical Systems, Inc.'s devices?
Among its 24 most recently registered devices, Smiths Industries Medical Systems, Inc. has devices listed in FDA 510(k) (23 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Smiths Industries Medical Systems, Inc.'s devices fall under?
Among its 24 most recently registered devices, the classes recorded for Smiths Industries Medical Systems, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
What are the newest devices from Smiths Industries Medical Systems, Inc. in the registry?
The most recently registered devices listed for Smiths Industries Medical Systems, Inc. include PERCUTANEOUS TRACHEOSTOMY KIT, PRO-VENT(TM), PULSATOR(R), AND LINE DRAW(TM) ARTERIAL BLOOD SAMPLING SYRINGES, SIMS CPAP SYSTEM and REGIONAL ANESTHESIA TRAYS.