Medical Device Manufacturer · US , Marietta , GA

Dornier Medtech America, Inc. - FDA 510(k) Cleared Devices

40 submissions · 40 cleared · Since 1990
40
Total
40
Cleared
0
Denied

FDA 510(k) cleared devices by Dornier Medtech America, Inc. Gastroenterology & Urology ✕

11 devices
1-11 of 11
Cleared Feb 22, 2023
Delta III Pro
K221903 · LNS
Gastroenterology & Urology · 237d
Cleared Jul 27, 2022
Dornier Thulio
K213252 · GEX
Gastroenterology & Urology · 300d
Cleared May 19, 2021
Electrosurgical accessory
K210394 · FAS
Gastroenterology & Urology · 98d
Cleared Nov 20, 2020
Dornier MAGELLAN Ureteral Access Sheath
K201815 · FED
Gastroenterology & Urology · 142d
Cleared Sep 03, 2020
Delta III Lithotripter
K201074 · LNS
Gastroenterology & Urology · 134d
Cleared Dec 06, 2019
EQUINOX Balloon Dilatation Catheter
K190612 · EZN
Gastroenterology & Urology · 270d
Cleared Nov 15, 2019
Dornier Ureteral Stent
K190312 · FAD
Gastroenterology & Urology · 276d
Cleared Sep 18, 2019
Dornier MINNOW Ureteral Catheter
K191187 · EYB
Gastroenterology & Urology · 138d
Cleared Aug 08, 2017
Delta III Lithotripter
K172084 · LNS
Gastroenterology & Urology · 29d
Cleared Sep 24, 2012
GEMINI LITHOTRIPTER
K121656 · LNS
Gastroenterology & Urology · 111d
Cleared Apr 17, 2001
DORNIER COMPACT ALPHA LITHOTRIPTER
K002929 · LNS
Gastroenterology & Urology · 209d
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