FDA applicant
Dentsleeve Pty., Ltd.
FDA records 3 decisions for Dentsleeve Pty., Ltd. (Parkside South Australia, AU) from 1998 to 2001: 3 510(k) clearances. Most are in product codes FFX (System, Gastrointestinal Motility (Electrical)) and KLA (Monitor, Esophageal Motility, Anorectal…). Its devices cite 1 predicate, 1 of them its own earlier devices. 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 Dentsleeve Pty., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Dentsleeve Pty., Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
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