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

FDA 510(k) Medical Device Manufacturers - Germany

German 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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Germany FDA 510(k) Overview

226

Manufacturers

734

Submissions

99%

Clearance rate

Leading Germany FDA 510(k) manufacturers include Brainlab AG, Siemens Healthcare GmbH, Karl Storz SE & CO. KG and 231 others.

German medical device manufacturers have submitted 734 FDA 510(k) notifications since 1996, achieving a 99.5% clearance rate. Germany's 226 FDA-active manufacturers reflect the country's established position in precision engineering and medical technology, with particular strength in imaging, surgical instruments and laboratory diagnostics.

Active in FDA 510(k) submissions since 1996. Many Germany manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Germany Manufacturers

1–50 of 234

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Brainlab AG Heimstetten	135	100%	EN NE OR +1	DE
2	Siemens Healthcare GmbH Erlangen	26	100%	RA	DE
3	Karl Storz SE & CO. KG Tuttlingen	25	100%	EN GU OB +1	DE
4	Implantcast GmbH Buxtehude	18	100%	OR	DE
5	Stryker Leibinger GmbH & Co KG Freiburg Im Breisgau	17	100%	DE NE OR +1	DE
6	Philips Medizin Systeme Boeblingen GmbH B?blingen	16	100%	CV OB	DE
7	PAJUNK GmbH Medizintechnologie Geisingen	13	100%	AN NE PM	DE
8	Heidelberg Engineering GmbH Heidelberg	13	100%	OP	DE
9	Zimmer Medizinsysteme GmbH Neu-Ulm	12	100%	GU PM SU	DE
10	Siemens Healthcare Diagnostics Products GmbH Marburg	11	91%	CH HE IM	DE
11	QIAGEN GmbH Hilden	10	100%	MI	DE
12	Silony Medical GmbH Leinfelden-Echterdingen	10	100%	OR	DE
13	Heraeus Medical GmbH Wehrheim	10	100%	OR	DE
14	Durr Dental SE Bietigheim-Bissingen	9	100%	RA	DE
15	Philips Medizin Systeme B?blingen GmbH Boeblingen	9	100%	AN CV	DE
16	Ulrich GmbH & Co. KG Ulm	8	100%	HO OR	DE
17	Aap Implantate AG Berlin	7	100%	OR	DE
18	Livanova Deutschland, GmbH Munich	7	100%	CV	DE
19	Vitromed GmbH Jena	7	100%	OB	DE
20	NGMedical GmbH Nonnweiler	7	100%	OR	DE
21	Sutter Medizintechnik GmbH Emmendingen	6	100%	EN SU	DE
22	Draegerwerk AG & CO Kgaa L?beck	6	100%	AN	DE
23	Ovesco Endoscopy AG Karlsruhe	6	100%	GU	DE
24	Fiagon GmbH Hennigsdorf	6	100%	EN OR	DE
25	Dental Direkt GmbH Spenge	6	100%	DE	DE
26	Osartis GmbH Dieburg	6	100%	OR	DE
27	Dr?gerwerk AG & Co KGaA Luebeck	5	100%	AN CV HO	DE
28	Inomed Medizintechnik GmbH Emmendingen	5	100%	EN NE	DE
29	Kettenbach GmbH & Co. KG Eschenburg	5	100%	DE	DE
30	Deltamed GmbH Friedberg	5	100%	DE	DE
31	Contract Medical International, GmbH Dresden	5	100%	CV	DE
32	Jk Holding GmbH Windhagen	5	100%	SU	DE
33	Dreve Dentamid GmbH Unna	5	100%	DE	DE
34	Mag & More GmbH Munich	5	100%	NE	DE
35	Envisiontec GmbH Gladbeck	5	100%	DE	DE
36	3M Espe Dental Products Bavaria D-82228 Seefeld	4	100%	DE	DE
37	Noras Mri Products GmbH Hoechberg	4	100%	RA	DE
38	Rapid Biomedical GmbH Rimpar	4	100%	RA	DE
39	Aktormed GmbH Barbing	4	100%	SU	DE
40	Lap GmbH Laser Applikationen Lueneburg	4	100%	RA	DE
41	Visus Health IT GmbH Bochum	4	100%	RA	DE
42	Pro3dure Medical GmbH Iserlohn	4	100%	DE	DE
43	Adeor Medical AG Valley	3	100%	NE SU	DE
44	3M Deutschland GmbH Bavaria D-82228 Seefeld	3	100%	DE	DE
45	Alber GmbH Albstadt	3	100%	PM	DE
46	Eit Emerging Implant Technologies GmbH Wurmlingen	3	100%	OR	DE
47	Maquet GmbH Rastatt	3	100%	HO	DE
48	Eresearchtechnology GmbH Estenfeld	3	100%	AN CV	DE
49	Mt. Derm GmbH Berlin	3	100%	SU	DE
50	Miha Bodytec GmbH Gersthofen	3	100%	PM	DE

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.