Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

40 results for "Dornier Medtech America, Inc."
1–24 of 40
Search insights Median review: 87d Cleared: 100% Top manufacturer: Dornier Medtech America, Inc. Lead specialty: General & Plastic Surgery
Cleared Feb 22, 2023
Delta III Pro
K221903 · LNS
Dornier Medtech America, Inc.
Gastroenterology & Urology · 237d
Cleared Jul 27, 2022
Dornier Thulio
K213252 · GEX
Dornier Medtech America, Inc.
Gastroenterology & Urology · 300d
Cleared Apr 18, 2022
Nautilus
K220871 · JAA
Dornier Medtech America, Inc.
Radiology · 24d
Cleared May 19, 2021
Electrosurgical accessory
K210394 · FAS
Dornier Medtech America, Inc.
Gastroenterology & Urology · 98d
Cleared Nov 20, 2020
Dornier MAGELLAN Ureteral Access Sheath
K201815 · FED
Dornier Medtech America, Inc.
Gastroenterology & Urology · 142d
Cleared Sep 03, 2020
Delta III Lithotripter
K201074 · LNS
Dornier Medtech America, Inc.
Gastroenterology & Urology · 134d
Cleared Dec 06, 2019
EQUINOX Balloon Dilatation Catheter
K190612 · EZN
Dornier Medtech America, Inc.
Gastroenterology & Urology · 270d
Cleared Nov 15, 2019
Dornier Ureteral Stent
K190312 · FAD
Dornier Medtech America, Inc.
Gastroenterology & Urology · 276d
Cleared Sep 18, 2019
Dornier MINNOW Ureteral Catheter
K191187 · EYB
Dornier Medtech America, Inc.
Gastroenterology & Urology · 138d
Cleared Aug 08, 2017
Delta III Lithotripter
K172084 · LNS
Dornier Medtech America, Inc.
Gastroenterology & Urology · 29d
Cleared Jul 28, 2016
Medilas H Laser Fibers
K161771 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 30d
Cleared Oct 08, 2015
Medilas H RFID Laser Fibers
K152591 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 28d
Cleared Jun 30, 2015
GENESIS
K151485 · JAA
Dornier Medtech America, Inc.
Radiology · 28d
Cleared Nov 26, 2014
GENESIS II
K133434 · JAA
Dornier Medtech America, Inc.
Radiology · 383d
Cleared Mar 21, 2013
DORNIER MEDILAS UROPULSE
K130344 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 38d
Cleared Feb 01, 2013
DORNIER MEDILAS H30 SOLVO
K122159 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 196d
Cleared Jan 18, 2013
GENESIS
K122768 · JAA
Dornier Medtech America, Inc.
Radiology · 130d
Cleared Dec 14, 2012
MEDILAS H LASER FIBERS
K123385 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 42d
Cleared Sep 24, 2012
GEMINI LITHOTRIPTER
K121656 · LNS
Dornier Medtech America, Inc.
Gastroenterology & Urology · 111d
Cleared Aug 01, 2012
MEDILAS H RFID LASER FIBER
K121938 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 30d
Cleared Dec 07, 2011
DORNIER MEDILAS D LITEBEAM+ 1470
K110364 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 303d
Cleared Feb 12, 2009
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM,...
K083500 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 79d
Cleared Jan 30, 2009
MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM,...
K083258 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 87d
Cleared Aug 20, 2008
MEDILAS D FAMILY LASERS
K073427 · GEX
Dornier Medtech America, Inc.
General & Plastic Surgery · 258d