Mallinckrodt Medical
Country not established FDA
- Devices
- 43
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Mallinckrodt Medical makes
Mallinckrodt Medical produces medical devices including guiding catheters for vascular procedures, anesthesia ventilators for patient respiration support, and tracheostomy tubes with low-pressure cuffs and disposable inner cannulas. Their portfolio also covers heat and moisture exchangers for respiratory therapy, esophageal stethoscopes with temperature sensors, and infusion catheters for fluid administration. Additional products include endotracheal tubes with evacuation capabilities, disposable auxiliary shields for tracheostomy tubes, and moisture management systems like HygroBac and HygroLife for patient care.
The company’s devices are classified under FDA’s Class I and Class II categories, with most requiring 510(k) clearance. These products are listed in the FDA’s 510(k) registry, reflecting their regulatory status in the United States. The manufacturer operates from its base in the US.
Catalogue
Search and filter all 43 devicesFDA establishments
- Mallinckrodt Medical ATHLONE Westmeath · IE FEI 3003382061
Frequently asked questions
How many devices does Mallinckrodt Medical have in the registry?
The registry currently lists 43 devices for Mallinckrodt Medical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mallinckrodt Medical's devices?
Among its 43 most recently registered devices, Mallinckrodt Medical has devices listed in FDA 510(k) (43 devices).
What risk classes do Mallinckrodt Medical's devices fall under?
Among its 43 most recently registered devices, the classes recorded for Mallinckrodt Medical's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Mallinckrodt Medical in the registry?
The most recently registered devices listed for Mallinckrodt Medical include PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER, SOFTOUCH GUIDING CATHETER, MALLARD MEDICAL MODEL 2400 ANESTHESIA VENTILATOR and HYGROBAC, S HYGROBOY AND HYGROBABY.
Which FDA establishments are linked to Mallinckrodt Medical?
1 FDA establishment is linked to Mallinckrodt Medical in the registry; they are listed on the company page.