Chrysalis Intelligence · Sponsors · Dornier Medtech America, Inc.

Dornier Medtech America, Inc.

Kennesaw, GA, US · 8 510(k) clearances

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Total clearances
8
2020-09-03 → 2025-01-31
Last 12 months
0
Product codes
5
Most recent
2025-01-31
Name variants in FDA filings: Dornier Medtech America, Inc. / Dornier Medtech America
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
FED Endoscopic Access Overtube, Gastroenterology-Urology Class II Gastroenterology, Urology 2 2025-01-31
JAA System, X-Ray, Fluoroscopic, Image-Intensified Class II Radiology 2 2024-06-26
LNS Lithotriptor, Extracorporeal Shock-Wave, Urological Class II Gastroenterology, Urology 2 2023-02-22
GEX Powered Laser Surgical Instrument Class II General, Plastic Surgery 1 2022-07-27
FAS — — — 1 2021-05-19
Filings

All 510(k) clearances (8)

Date K-number Device Code Class Specialty
2025-01-31 K243820 Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s IVX-NS-1040, IVX-NS-1050, IVX-NS-1140, IVX-NS-1150, IVX-NS-1240, IVX-NS-1250 FED Class II Gastroenterology, Urology
2024-06-26 K233380 TRIDENT Mobile Fluoroscopy System JAA Class II Radiology
2023-02-22 K221903 Delta III Pro LNS Class II Gastroenterology, Urology
2022-07-27 K213252 Dornier Thulio GEX Class II General, Plastic Surgery
2022-04-18 K220871 Nautilus JAA Class II Radiology
2021-05-19 K210394 Electrosurgical accessory FAS — —
2020-11-20 K201815 Dornier MAGELLAN Ureteral Access Sheath FED Class II Gastroenterology, Urology
2020-09-03 K201074 Delta III Lithotripter LNS Class II Gastroenterology, Urology
Data source: openFDA · Generated 2026-08-27 08:58 · Last ingest 2026-08-27T12:58:10.687222 · Pipeline: Chrysalis Intelligence