FDA applicant

Access Cardiosystems, Inc.

Concord, MA2 decisions2002–20022 recalls

FDA records 2 decisions for Access Cardiosystems, Inc. (Concord, MA) in 2002: 2 510(k) clearances. Most are in product codes MKJ (Automated External Defibrillators (Non-Wearable)) and LDD (Dc-Defibrillator, Low-Energy, (Including…). Its devices cite 3 predicates, 0 of them its own earlier devices. 2 recalls are 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 Access Cardiosystems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Access Cardiosystems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Access”

FDA records each applicant name separately; these may or may not be the same firm.

Access Scientific, Inc. 14 Access Surgical Intl., Inc. 9 Access Vascular, Inc. 9 Access / God Loves You 4 Access Point Medical, LLC 4 Access Bio Incorporate 4 Access Bio, Inc. 3 Access Devices, Inc. 3 Access Pharmaceuticals, Inc. 2 Access Battery, Inc. 2 Access Radiology Corp. 2 Access Point Technologies Ep, Inc. 1

Access Cardiosystems, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Access”