9 results
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38ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
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Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 15mm-16.5mm-18mm, REF 1205-18
FDA Enforcement
Class II
·Ongoing·Diversatek Healthcare·April 29, 2026
Diversatek Healthcare Viper¿ 3-Stage Fixed Wire Balloon Dilator, 6mm-7mm-8mm, REF 1204-08
FDA Enforcement
Class II
·Ongoing·Diversatek Healthcare·April 29, 2026
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 12mm-13.5mm-15mm, REF 1205-15
FDA Enforcement
Class II
·Ongoing·Diversatek Healthcare·April 29, 2026
Diversatek Healthcare Viper¿ 3-Stage Wire Guided Balloon Dilator, 18mm-19mm-20mm, REF 1205-20
FDA Enforcement
Class II
·Ongoing·Diversatek Healthcare·April 29, 2026
Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve, Biopsy Valve Manufactured for: Diversatek Healthcare 102 E.Keefe Ave. Milwaukee, WI 53212 USA Product Code: 1203-71
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
Bulldog Disposable Endoscope Valves Set-Air/Water Valve, Suction Valve,Biopsy Valve,Auxiliary Water Jet Connector Diversatek Healthcare 102 E.Keefe Ave. Milwaukee,WI 53212 USA Product Code: 1203-72
FDA Enforcement
Class II
·Terminated·GA HEALTH COMPANY LIMITED·December 30, 2020
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10
FDA Enforcement
Class III
·Ongoing·Diversatek Healthcare·August 20, 2025
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.
FDA Enforcement
Class II
·Terminated·Diversatek Healthcare·September 28, 2022
ZVU Functional GI Software, REF: ZVU-3
FDA Enforcement
Class III
·Ongoing·Diversatek Healthcare·September 13, 2023