Dornier Medtech America is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Dornier Medtech America - FDA 510(k) Cleared Devices
Recent clearances: 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, TRIDENT Mobile Fluoroscopy System, Dornier Medilas H Solvo 35 Laser
6
Total
6
Cleared
0
Denied
Dornier Medtech America has 6 FDA 510(k) cleared medical devices. Based in Kennesaw, US.
Latest FDA clearance: Jan 2025. Active since 2013. Primary specialty: Gastroenterology & Urology.
Browse the FDA 510(k) cleared devices submitted by Dornier Medtech America Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - Dornier Medtech America
6 devices
Cleared
Jan 31, 2025
Hoover Negative Pressure Access Sheath (Hoover) (Hoover Model #'s...
Gastroenterology & Urology
50d
Cleared
Jun 26, 2024
TRIDENT Mobile Fluoroscopy System
Radiology
268d
Cleared
Mar 07, 2018
Dornier Medilas H Solvo 35 Laser
General & Plastic Surgery
27d
Cleared
Jun 28, 2017
Delta III Lithotripter
Gastroenterology & Urology
166d
Cleared
Jul 30, 2015
Gemini XXP-HP
Gastroenterology & Urology
76d
Cleared
Sep 23, 2013
EXTRA CORPOREAL SHOCKWAVE LITHOTRIPTER
Gastroenterology & Urology
27d