American Biomaterials Corp.
United StatesFDA applicant, unverified
- Devices
- 6
What American Biomaterials Corp. makes
American Biomaterials Corp. manufactures medical devices including sterile IV start kits for venous access, dental implants like the Bioglass endosseous ridge maintainer, and ossicular reconstruction prostheses for middle ear repair. Their portfolio also includes catheters such as the Evert-O-Cath, microsurgical instruments for precision procedures, and a hole punch for surgical applications.
The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II. These devices are listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Creative Care Systems' Iv Start Kit Ref K863796
Regimes: 510(k) Registry: 510(k)Bioglass Dental Endosseous Ridge Maintainer Ref K880371
Regimes: 510(k) Registry: 510(k)Evert-O-Cath Catheter Ref K922455
Regimes: 510(k) Registry: 510(k)Bioglass Ossicular Reconstruction Prosth Ref K843461
Regimes: 510(k) Registry: 510(k)Hole Punch Ref K915824
Regimes: 510(k) Registry: 510(k)American Biomed, Inc. Microsurgical Instruments Ref K924725
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Biomaterials Corp. have in the registry?
The registry currently lists 6 devices for American Biomaterials Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Biomaterials Corp.'s devices?
Among its 6 most recently registered devices, American Biomaterials Corp. has devices listed in FDA 510(k) (6 devices).
What risk classes do American Biomaterials Corp.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for American Biomaterials Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Biomaterials Corp. in the registry?
The most recently registered devices listed for American Biomaterials Corp. include CREATIVE CARE SYSTEMS' IV START KIT, BIOGLASS DENTAL ENDOSSEOUS RIDGE MAINTAINER, EVERT-O-CATH CATHETER and BIOGLASS OSSICULAR RECONSTRUCTION PROSTH.