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

233

Manufacturers

1,071

Submissions

100%

Clearance rate

Leading Germany FDA 510(k) manufacturers include Brainlab AG, Philips Medizin Systeme Boeblingen GmbH, Wieland Dental + Technik GmbH & Co. KG and 231 others.

German medical device manufacturers have submitted 1,071 FDA 510(k) notifications since 1990, achieving a 99.6% clearance rate. Germany's 233 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 1990. 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	Philips Medizin Systeme Boeblingen GmbH B?blingen	48	100%	AN CV OB +1	DE
3	Wieland Dental + Technik GmbH & Co. KG Pforzheim	45	100%	DE	DE
4	PAJUNK GmbH Medizintechnologie Geisingen	44	100%	AN CV GU +5	DE
5	Aap Implantate AG Berlin	37	100%	OR	DE
6	Degussa AG West Germany	33	100%	DE	DE
7	Siemens AG Medical Solutions Forchheim	31	100%	RA	DE
8	Siemens Healthcare GmbH Erlangen	31	100%	RA	DE
9	Rudolf Riester GmbH & Co. KG D-72417 Jungingen	30	100%	AN CV EN +3	DE
10	Espe Dental AG Bavaria D-82228 Seefeld	29	100%	DE	DE
11	Karl Storz SE & CO. KG Tuttlingen	26	100%	EN GU OB +1	DE
12	Philips Medizinsysteme Boeblingen GmbH, Cardiac AN Boeblingen, Baden-Wuerttemberg	25	100%	AN CV OB	DE
13	3M Espe AG Dental Products Bavaria D-82228 Seefeld	24	100%	DE	DE
14	Ulrich GmbH & Co. KG Ulm	24	100%	CV HO OR	DE
15	Stryker Leibinger GmbH & Co KG Freiburg Im Breisgau	22	100%	DE NE OR +1	DE
16	Implantcast GmbH Buxtehude	18	100%	OR	DE
17	Heidelberg Engineering GmbH Heidelberg	13	100%	OP	DE
18	Zimmer Medizinsysteme GmbH Neu-Ulm	12	100%	GU PM SU	DE
19	Siemens Healthcare Diagnostics Products GmbH Marburg	11	91%	CH HE IM	DE
20	QIAGEN GmbH Hilden	10	100%	MI	DE
21	Silony Medical GmbH Leinfelden-Echterdingen	10	100%	OR	DE
22	Heraeus Medical GmbH Wehrheim	10	100%	OR	DE
23	Durr Dental SE Bietigheim-Bissingen	9	100%	RA	DE
24	Philips Medizin Systeme B?blingen GmbH Boeblingen	9	100%	AN CV	DE
25	Livanova Deutschland, GmbH Munich	7	100%	CV	DE
26	Vitromed GmbH Jena	7	100%	OB	DE
27	NGMedical GmbH Nonnweiler	7	100%	OR	DE
28	Sutter Medizintechnik GmbH Emmendingen	6	100%	EN SU	DE
29	Draegerwerk AG & CO Kgaa L?beck	6	100%	AN	DE
30	Ovesco Endoscopy AG Karlsruhe	6	100%	GU	DE
31	Fiagon GmbH Hennigsdorf	6	100%	EN OR	DE
32	Dental Direkt GmbH Spenge	6	100%	DE	DE
33	Osartis GmbH Dieburg	6	100%	OR	DE
34	Dr?gerwerk AG & Co KGaA Luebeck	5	100%	AN CV HO	DE
35	Inomed Medizintechnik GmbH Emmendingen	5	100%	EN NE	DE
36	Kettenbach GmbH & Co. KG Eschenburg	5	100%	DE	DE
37	Deltamed GmbH Friedberg	5	100%	DE	DE
38	Contract Medical International, GmbH Dresden	5	100%	CV	DE
39	Jk Holding GmbH Windhagen	5	100%	SU	DE
40	Dreve Dentamid GmbH Unna	5	100%	DE	DE
41	Mag & More GmbH Munich	5	100%	NE	DE
42	Envisiontec GmbH Gladbeck	5	100%	DE	DE
43	3M Espe Dental Products Bavaria D-82228 Seefeld	4	100%	DE	DE
44	Noras Mri Products GmbH Hoechberg	4	100%	RA	DE
45	Rapid Biomedical GmbH Rimpar	4	100%	RA	DE
46	Aktormed GmbH Barbing	4	100%	SU	DE
47	Lap GmbH Laser Applikationen Lueneburg	4	100%	RA	DE
48	Visus Health IT GmbH Bochum	4	100%	RA	DE
49	Pro3dure Medical GmbH Iserlohn	4	100%	DE	DE
50	Adeor Medical AG Valley	3	100%	NE SU	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.