Diversatek Healthcare
Diversatek Healthcare holds FDA 510(k) medical device clearances, first cleared 2019, most recent 2023, with 7 FDA device recalls on record.
Top product codes for Diversatek Healthcare
FDA recalls by Diversatek Healthcare
- Z-1940-2026 — Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
- Z-1939-2026 — Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
- Z-1941-2026 — Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
- Z-1938-2026 — Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
- Z-2324-2025 — Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
- Z-2521-2023 — ZVU Functional GI Software, REF: ZVU-3
- Z-1771-2022 — Diversatek Health, M-Catch Retrieval Nets, Part Number REF 1175-01, Quantity 5 EA/u. Used to endoscopically retrieve severed polyps, tissue samples, food bolus, and foreign bodies in the gastrointestinal tract.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Diversatek Healthcare
Data sourced from openFDA. This site is unofficial and independent of the FDA.