Integra Lifesciences Corporation
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000007196 FEI 3004608878
- Devices
- 71
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Integra Lifesciences Corporation makes
The company produces intracranial pressure monitoring systems, including disposable skull pins, external drainage kits, and brain monitoring probes, as well as electrosurgical tools and interconnecting cables for surgical use. Its portfolio also includes wound care matrices for soft tissue regeneration, bone fixation systems for orthopedic applications, and joint fusion devices such as wrist and shoulder arthroplasty systems. Additional offerings cover dural regeneration matrices for spinal surgery and bone regeneration putties for reconstructive procedures.
These devices are regulated under FDA classifications, with most falling into Class II and Class III categories, while some are exempt under Class U. Authorisation records include 510(k) clearances and Premarket Approvals (PMAs), and the company is based in the United States.
Catalogue
Search and filter all 71 devicesShowing 1-50 of 71
Company details
- EUDAMED SRN
- US-MF-000007196
- FDA FEI number
- 3004608878
- DUNS number
- 083171244
- EUDAMED status
- Active
- EUDAMED registered name
- Integra LifeSciences Corporation
- EUDAMED abbreviated name
- Integra - Princeton
- Registered address
- 1100, Campus Road, 08540, Princeton, NJ, United States
- [email protected]
- Phone
- +1(800)654-2873
- PRRC contact
- Kerri DiPietro
1 more person
- Dean Ripploh
Frequently asked questions
How many devices does Integra Lifesciences Corporation have in the registry?
The registry currently lists 71 devices for Integra Lifesciences Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Integra Lifesciences Corporation's devices?
Among its 50 most recently registered devices, Integra Lifesciences Corporation has devices listed in EUDAMED (2 devices), FDA 510(k) (48 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Integra Lifesciences Corporation's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Integra Lifesciences Corporation'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 Integra Lifesciences Corporation in the registry?
The most recently registered devices listed for Integra Lifesciences Corporation include DuraGen® Suturable, MAYFIELD®, INTEGRA FLOW REGULATING VALVE SYSTEMS OSV II MODELS AND INTEGRA FLOW REGULATING VALVE LOW FLOW MODELS and INTEGRA Wound Matrix (Macro-Channels).