510(k) Report

FDA applicant

Ultramed, Inc.

North Brunswick, NJ5 decisions1985–19880 recalls

FDA records 5 decisions for Ultramed, Inc. (North Brunswick, NJ) from 1985 to 1988: 5 510(k) clearances. Most are in product codes JOP (Transducer, Ultrasonic) and HQC (Unit, Phacofragmentation). 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, cardiovascular panel, where it files most

How often FDA has decided Ultramed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ultramed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ultramed, 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?

  • JOPTransducer, Ultrasonic2decisions
  • HQCUnit, Phacofragmentation2decisions
  • IYNSystem, Imaging, Pulsed Doppler, Ultrasonic1decision

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K861378Ultramed TF 122 Ultrason Vascu Imag & Doppler SystUltramed, Inc. · 19861cites it

What has FDA decided for it lately?

  • K882015Transcran (TM) Transcranial Pulsed Doppler SystemUltramed, Inc. · 1988
  • K873989Dopplex Ultrasonic Doppler SystemUltramed, Inc. · 1988
  • K861378Ultramed TF 122 Ultrason Vascu Imag & Doppler SystUltramed, Inc. · 1986
  • K862021Phacoemulsification Ultrasonic Fragment SystemUltramed, Inc. · 1986
  • K850578Phacoemulsification TipUltramed, Inc. · 1985

All 5 as Ultramed, Inc. →