Bausch & Lomb Pharmaceutical, Inc.
United StatesFDA applicant, unverified
- Devices
- 6
What Bausch & Lomb Pharmaceutical, Inc. makes
The company manufactures collagen corneal implants, including the Bio-COR EXT, Bio-COR II, and Fyodorov collagen corneal devices, with updates to labeling and additional indications for specific models.
These devices are classified as Class I and Class II under FDA regulations, with submissions recorded via the 510(k) pathway. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Labeling Changes To Bio-Cor Ii Collangen Corneal Ref K884363
Regimes: 510(k) Registry: 510(k)Addit. Indication For Fyodorov Collagen Corneal Ref K884960
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bausch & Lomb Pharmaceutical, Inc. have in the registry?
The registry currently lists 6 devices for Bausch & Lomb Pharmaceutical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bausch & Lomb Pharmaceutical, Inc.'s devices?
Among its 6 most recently registered devices, Bausch & Lomb Pharmaceutical, Inc. has devices listed in FDA 510(k) (6 devices).
What risk classes do Bausch & Lomb Pharmaceutical, Inc.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Bausch & Lomb Pharmaceutical, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bausch & Lomb Pharmaceutical, Inc. in the registry?
The most recently registered devices listed for Bausch & Lomb Pharmaceutical, Inc. include LABELING CHANGES TO BIO-COR EXT COLLANGEN CORNEAL, ADDIT. INDICATIONS FOR BIO-COR II COLLAGEN CORNEAL, ADDIT. INDICATIONS FOR BIO-COR EXT COLLAGEN CORNEA and LABELING CHANGES TO BIO-COR II COLLANGEN CORNEAL.