FDA applicant

Cambridge Assoc.

Beverly, MA1 decision1997–19970 recalls

FDA records 1 decision for Cambridge Assoc. (Beverly, MA) in 1997: 1 510(k) clearance. All are in product code LWF (Dilator, Nasal). 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

No FDA decision for Cambridge Assoc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cambridge Assoc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Cambridge”

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

Cambridge Heart, Inc. 17 Cambridge Medical Technology 14 Cambridge Instruments, Inc. 13 Cambridge Medical Instruments, Inc. 8 Cambridge Bioscience Corp. 5 Cambridge Nuclear Corp. 5 Cambridge Chemical Products, Inc. 4 Cambridge Diagnostics Ireland, Ltd. 4 Cambridge Life Sciences Plc. 4 Cambridge Sensors Limited 3 Cambridge Biotech Corp. 3 Cambridge Scientific 2

Cambridge Assoc.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Cambridge”