B&B Medical Assoc., Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What B&B Medical Assoc., Inc. makes
B&B Medical produces surgical instruments for vitreoretinal procedures, including oscillating and guillotine vitrectors, an infusion handle for intraocular fluid management, and an intraocular fluid injector.
The company’s devices are classified as Class I and Class II under FDA regulations, with some models requiring 510(k) clearance. These products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Vac-G (Guillotine Vitrector) Ref K881519
Regimes: 510(k) Registry: 510(k)B & B I/A Handpiece Ref K881517
Regimes: 510(k) Registry: 510(k)Introcular Fluid Injector Ref K881707
Regimes: 510(k) Registry: 510(k)Infusion Handle Ref K881518
Regimes: 510(k) Registry: 510(k)Vac (Oscillating Vitrector) Ref K881520
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does B&B Medical Assoc., Inc. have in the registry?
The registry currently lists 5 devices for B&B Medical Assoc., Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list B&B Medical Assoc., Inc.'s devices?
Among its 5 most recently registered devices, B&B Medical Assoc., Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do B&B Medical Assoc., Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for B&B Medical Assoc., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from B&B Medical Assoc., Inc. in the registry?
The most recently registered devices listed for B&B Medical Assoc., Inc. include VAC-G (GUILLOTINE VITRECTOR), B & B I/A HANDPIECE, INTROCULAR FLUID INJECTOR and INFUSION HANDLE.