510(k) Report

FDA applicant

B&B Medical Assoc., Inc.

Danvers, MA5 decisions1988–19880 recalls

FDA records 5 decisions for B&B Medical Assoc., Inc. (Danvers, MA) in 1988: 5 510(k) clearances. Most are in product codes HQE (Instrument, Vitreous Aspiration And Cutting…) and KYG (Device, Irrigation, Ocular Surgery). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided B&B Medical Assoc., Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for B&B Medical Assoc., Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — B&B Medical Assoc., Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered2decisions
  • KYGDevice, Irrigation, Ocular Surgery2decisions
  • FIHPump, Infusion Or Syringe, Extra-Luminal1decision

What has FDA decided for it lately?

  • K881707Introcular Fluid InjectorB&B Medical Assoc., Inc. · 1988
  • K881519Vac-G (Guillotine Vitrector)B&B Medical Assoc., Inc. · 1988
  • K881520Vac (Oscillating Vitrector)B&B Medical Assoc., Inc. · 1988
  • K881518Infusion HandleB&B Medical Assoc., Inc. · 1988
  • K881517B & B I/a HandpieceB&B Medical Assoc., Inc. · 1988

All 5 as B&B Medical Assoc., Inc. →