Manufacturer Intelligence · Based on 21,482 FDA 510(k) records · 72 countries

FDA 510(k) Medical Device Manufacturers - Austria

Name: FDA 510(k) Medical Device Manufacturers
Creator: 510k Database

Austrian medical device manufacturers ranked by FDA 510(k) submission volume. This is not a curated directory - rankings reflect real submission activity extracted from FDA accessdata.gov records.

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Manufacturers

Austria

Country

Austria FDA 510(k) Overview

Manufacturers

Submissions

98%

Clearance rate

Leading Austria FDA 510(k) manufacturers include Med-El Elektromedizinische Ger?te GmbH, W&H Dentalwerk Buermoos GmbH, Klaxon Mobility GmbH and 25 others.

Austrian medical device manufacturers have submitted 43 FDA 510(k) notifications since 2019, achieving a 97.7% clearance rate across 28 manufacturers. Austria's medtech sector reflects the country's precision manufacturing tradition, with activity in surgical instruments, diagnostic devices and specialty medical equipment.

Active in FDA 510(k) submissions since 2019. Many Austria manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Austria Manufacturers

1–28 of 28

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Med-El Elektromedizinische Ger?te GmbH Innsbruck	6	100%	EN	AT
2	W&H Dentalwerk Buermoos GmbH Buermoos	3	100%	DE EN	AT
3	Klaxon Mobility GmbH Arnoldstein	3	100%	PM	AT
4	G.Tec Medical Engineering GmbH Schiedlberg	2	100%	NE PM	AT
5	Medphoton GmbH Salzburg	2	100%	RA	AT
6	Med-El Elektromedizinische Geraete GmbH Innsbruck	2	100%	EN	AT
7	W&H Dentalwerk Buermoss GmbH Burmoos	2	100%	DE	AT
8	Thi Total Healthcare Innovation GmbH Feistritz Im Rosental	2	100%	HO	AT
9	Piur Imaging GmbH Vienna	2	100%	RA	AT
10	Cnsystems Medizintechnik GmbH Europe	1	100%	CV	AT
11	Otto Bock Healthcare Products GmbH Vienna	1	100%	NE	AT
12	Agency For Medical Innovations GmbH Feldkirch	1	100%	OB	AT
13	Ait Austrian Institute of Technology GmbH Vienna	1	100%	NE	AT
14	Csd Labs GmbH Graz	1	100%	CV	AT
15	Semperit Technische Produkte Gesellchaft M.B.H. Wimpassing	1	100%	HO	AT
16	Ib Lab GmbH Vienna	1	100%	RA	AT
17	Austrian Institute of Technology GmbH Vienna	1	100%	NE	AT
18	Technoclone Herstellung Von Diagnostika Und Arzneimitteln GM Vienna	1	0%	HE	AT
19	Biolux Technology GmbH Absdorf	1	100%	DE	AT
20	Steadysense GmbH Seiersberg Pirka	1	100%	HO	AT
21	Edelweiss Dentistry Products GmbH Wolfurt	1	100%	DE	AT
22	W&H Dentalwerk B?rmoos GmbH Buermoos	1	100%	DE	AT
23	Bhm-Tech Produktionsgesellschaft Mbh Grafenschachen	1	100%	EN	AT
24	P.G.F. Industry Solutions GmbH Elixhausen	1	100%	SU	AT
25	A.M.I. Agency For Medical Innovations GmbH Feldkirch	1	100%	OB	AT
26	Harps Europe Manufacturing GmbH Niederosterreich	1	100%	HO	AT
27	Ec Certification Service GmbH Sankt Veit An Der Glan	1	100%	DE	AT
28	Csd Labs Graz	1	100%	CV	AT

About This FDA 510(k) Manufacturer Database

Data Source and Methodology

Rankings are based on the total number of published FDA 510(k) submissions per manufacturer in the 510k Database dataset, derived from FDA 510(k) public files. This is not a curated or paid listing - manufacturer rankings reflect real regulatory activity.

Used by regulatory affairs teams and medtech consultants to benchmark manufacturer activity, identify predicate device candidates, and analyze competitive positioning across FDA review panels.