Medical Device Manufacturer · US , Marietta , GA

Dornier Medtech America, Inc.

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

Dornier Medtech America, Inc. — FDA 510(k) Submissions

Dornier Medtech America, Inc. has submitted 40 FDA 510(k) premarket notifications since 1990, of which 40 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Powered Laser Surgical Instrument, Lithotriptor, Extracorporeal Shock-wave, Urological, System, X-ray, Fluoroscopic, Image-intensified, Endoscopic Access Overtube, Gastroenterology-urology, Electrode, Electrosurgical, Active, Urological . Use the specialty filter in the sidebar to narrow results.

40 devices
1–25 of 40
Delta III Pro
K221903 · LNS Lithotriptor,... · Gastroenterology & Urology
Feb 2023 237d
Dornier Thulio
K213252 · GEX Powered Laser Surgical... · Gastroenterology & Urology
Jul 2022 300d
Nautilus
K220871 · JAA System, X-ray,... · Radiology
Apr 2022 24d
Electrosurgical accessory
K210394 · FAS Electrode,... · Gastroenterology & Urology
May 2021 98d
Dornier MAGELLAN Ureteral Access Sheath
K201815 · FED Endoscopic Access... · Gastroenterology & Urology
Nov 2020 142d
Delta III Lithotripter
K201074 · LNS Lithotriptor,... · Gastroenterology & Urology
Sep 2020 134d
EQUINOX Balloon Dilatation Catheter
K190612 · EZN Dilator, Catheter, Ureteral · Gastroenterology & Urology
Dec 2019 270d
Dornier Ureteral Stent
K190312 · FAD Stent, Ureteral · Gastroenterology & Urology
Nov 2019 276d
Dornier MINNOW Ureteral Catheter
K191187 · EYB Catheter, Ureteral,... · Gastroenterology & Urology
Sep 2019 138d
Delta III Lithotripter
K172084 · LNS Lithotriptor,... · Gastroenterology & Urology
Aug 2017 29d
Medilas H Laser Fibers
K161771 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jul 2016 30d
Medilas H RFID Laser Fibers
K152591 · GEX Powered Laser Surgical... · General & Plastic Surgery
Oct 2015 28d
GENESIS
K151485 · JAA System, X-ray,... · Radiology
Jun 2015 28d
GENESIS II
K133434 · JAA System, X-ray,... · Radiology
Nov 2014 383d
DORNIER MEDILAS UROPULSE
K130344 · GEX Powered Laser Surgical... · General & Plastic Surgery
Mar 2013 38d
DORNIER MEDILAS H30 SOLVO
K122159 · GEX Powered Laser Surgical... · General & Plastic Surgery
Feb 2013 196d
GENESIS
K122768 · JAA System, X-ray,... · Radiology
Jan 2013 130d
MEDILAS H LASER FIBERS
K123385 · GEX Powered Laser Surgical... · General & Plastic Surgery
Dec 2012 42d
GEMINI LITHOTRIPTER
K121656 · LNS Lithotriptor,... · Gastroenterology & Urology
Sep 2012 111d
MEDILAS H RFID LASER FIBER
K121938 · GEX Powered Laser Surgical... · General & Plastic Surgery
Aug 2012 30d
DORNIER MEDILAS D LITEBEAM+ 1470
K110364 · GEX Powered Laser Surgical... · General & Plastic Surgery
Dec 2011 303d
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
K083500 · GEX Powered Laser Surgical... · General & Plastic Surgery
Feb 2009 79d
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE
K083258 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jan 2009 87d
MEDILAS D FAMILY LASERS
K073427 · GEX Powered Laser Surgical... · General & Plastic Surgery
Aug 2008 258d
DORNIER MEDILAS D 30 LASER, MEDILAS D 1064
K080959 · GEX Powered Laser Surgical... · General & Plastic Surgery
Jun 2008 85d
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