FDA applicant
Medtel Pty., Ltd.
FDA records 8 decisions for Medtel Pty., Ltd. (Mchenry, IL) from 1979 to 1983: 8 510(k) clearances. Most are in product codes DRT (Monitor, Cardiac (Incl. Cardiotachometer &…) and DSK (Computer, Blood-Pressure). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Medtel Pty., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Medtel Pty., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Medtel Pty., 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) Report