Dornier Medtech America, Inc.

Country / region:United States (US)

510(k) submissions

4

Latest clearance

2022-07-27

Product codes

1

GEX

Cited as predicate

4

Product areas

FDA product code distribution

510(k) submissions

4 total

K number	Device name	Product code	Class	Decision date
K213252	Dornier Thulio	GEX	Class 2	2022-07-27
K180350	Dornier Medilas H Solvo 35 Laser	GEX	Class 2	2018-03-07
K161771	Medilas H Laser Fibers	GEX	Class 2	2016-07-28
K152591	Medilas H RFID Laser Fibers	GEX	Class 2	2015-10-08

Company profile

Canonical name: Dornier Medtech America, Inc.
Aliases: Dornier Medtech America
Country: United States(US)

Cited predicates

14

K121938
—
—
Not ingested
K152591
—
—
Not ingested
K161257
—
—
Not ingested
K161771
—
—
Not ingested
K170121
—
—
Not ingested
K180350
—
—
Not ingested
K201636
—
—
Not ingested
K984591
—
—
Not ingested
K122159
—
—
Not ingested
K163009
Litho
Quanta System Spa
K110685
—
—
Not ingested
K152591
—
—
Not ingested
K120926
—
—
Not ingested
K121938
—
—
Not ingested

Dornier Medtech America, Inc. references 14 predicate/reference devices

Cited as predicate

4

K213252
Dornier Thulio
Dornier Medtech America, Inc.
Not ingested
K213252
Dornier Thulio
Dornier Medtech America, Inc.
Not ingested
K213252
Dornier Thulio
Dornier Medtech America, Inc.
Not ingested
K161771
Medilas H Laser Fibers
Dornier Medtech America, Inc.
Not ingested

4 submissions cite Dornier Medtech America, Inc. as a predicate