FDA applicant
Reynolds Medical, Ltd.
FDA records 12 decisions for Reynolds Medical, Ltd. (Hasbrouck, NJ) from 1982 to 2003: 12 510(k) clearances. Most are in product codes DSH (Recorder, Magnetic Tape, Medical) and DXH (Transmitters And Receivers…). Its devices cite 10 predicates, 4 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
How often FDA has decided Reynolds Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Reynolds Medical, Ltd. since 2007.
Recalls per year
1in 2015
Class I Class II/III not classified
Planning a device like Reynolds Medical, Ltd.’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) ReportOther applicant names beginning “Reynolds”
FDA records each applicant name separately; these may or may not be the same firm.