Allied Biomedical Corp.
United StatesFDA applicant, unverified
- Devices
- 9
What Allied Biomedical Corp. makes
Allied Biomedical Corp. manufactures silicone-based implants and medical-grade tubing, including anatomical malar, chin, and nasal implants, as well as DURALASTIC silicone tubing for medical applications. Their product line also includes KELOCOTE adhesive and KELOCATE sheeting, designed for wound management and medical device fixation.
The company’s portfolio includes devices classified as Class I and Class II under FDA regulations, with several products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry, and the manufacturer operates from the United States.
Catalogue
Duralastic Ii Ref K955370
Regimes: 510(k) Registry: 510(k)Duralastic I Ref K955368
Regimes: 510(k) Registry: 510(k)Duralastic Anatomical Malar Implants Ref K971479
Regimes: 510(k) Registry: 510(k)Kelocate Sheeting Ref K982051
Regimes: 510(k) Registry: 510(k)Duralastic Silicone Tubing Ref K955433
Regimes: 510(k) Registry: 510(k)Kelocote Ref K954413
Regimes: 510(k) Registry: 510(k)Duralastic Anatomical Chin Implants Ref K971478
Regimes: 510(k) Registry: 510(k)Duralastic I And Duralastic Ii Ref K971480
Regimes: 510(k) Registry: 510(k)Duralastic Anatomical Nasal Implants Ref K971481
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Allied Biomedical Corp. have in the registry?
The registry currently lists 9 devices for Allied Biomedical Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Allied Biomedical Corp.'s devices?
Among its 9 most recently registered devices, Allied Biomedical Corp. has devices listed in FDA 510(k) (9 devices).
What risk classes do Allied Biomedical Corp.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Allied Biomedical Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Allied Biomedical Corp. in the registry?
The most recently registered devices listed for Allied Biomedical Corp. include DURALASTIC II, DURALASTIC I, DURALASTIC ANATOMICAL MALAR IMPLANTS and KELOCATE SHEETING.