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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Identify clearance rates, active panels and years of FDA activity

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Germany Manufacturers

1–50 of 176

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Brainlab AG Heimstetten	41	100%	EN NE OR +1	DE
2	Siemens Healthcare GmbH Erlangen	23	100%	RA	DE
3	Karl Storz SE & CO. KG Tuttlingen	22	100%	EN GU OB +1	DE
4	Implantcast GmbH Buxtehude	15	100%	OR	DE
5	Stryker Leibinger GmbH & Co KG Freiburg Im Breisgau	15	100%	DE NE OR +1	DE
6	PAJUNK GmbH Medizintechnologie Geisingen	10	100%	AN NE PM	DE
7	Zimmer Medizinsysteme GmbH Neu-Ulm	10	100%	GU PM SU	DE
8	Philips Medizin Systeme Boeblingen GmbH B?blingen	9	100%	CV OB	DE
9	QIAGEN GmbH Hilden	9	100%	MI	DE
10	Heidelberg Engineering GmbH Heidelberg	8	100%	OP	DE
11	Siemens Healthcare Diagnostics Products GmbH Marburg	8	88%	CH HE IM	DE
12	Philips Medizin Systeme B?blingen GmbH Boeblingen	8	100%	CV	DE
13	Ulrich GmbH & Co. KG Ulm	7	100%	HO OR	DE
14	Heraeus Medical GmbH Wehrheim	7	100%	OR	DE
15	NGMedical GmbH Nonnweiler	7	100%	OR	DE
16	Livanova Deutschland, GmbH Munich	6	100%	CV	DE
17	Inomed Medizintechnik GmbH Emmendingen	5	100%	EN NE	DE
18	Aap Implantate AG Berlin	5	100%	OR	DE
19	Draegerwerk AG & CO Kgaa L?beck	5	100%	AN	DE
20	Ovesco Endoscopy AG Karlsruhe	5	100%	GU	DE
21	Fiagon GmbH Hennigsdorf	5	100%	EN OR	DE
22	Durr Dental SE Bietigheim-Bissingen	5	100%	RA	DE
23	Vitromed GmbH Jena	5	100%	OB	DE
24	Dr?gerwerk AG & Co KGaA Luebeck	4	100%	AN CV HO	DE
25	Silony Medical GmbH Leinfelden-Echterdingen	4	100%	OR	DE
26	Deltamed GmbH Friedberg	4	100%	DE	DE
27	Dental Direkt GmbH Spenge	4	100%	DE	DE
28	Osartis GmbH Dieburg	4	100%	OR	DE
29	Envisiontec GmbH Gladbeck	4	100%	DE	DE
30	Noras Mri Products GmbH Hoechberg	3	100%	RA	DE
31	Contract Medical International, GmbH Dresden	3	100%	CV	DE
32	Mag & More GmbH Munich	3	100%	NE	DE
33	Morpheus AG Spaichingen	3	100%	NE	DE
34	Pro3dure Medical GmbH Iserlohn	3	100%	DE	DE
35	Surgvision GmbH Munich	3	100%	SU	DE
36	Detax GmbH Ettingen	3	100%	DE	DE
37	Whitepeaks Dental Solutions GmbH Essen	3	100%	DE	DE
38	Siemens Healthineers AG Forchheim	3	100%	RA	DE
39	Sutter Medizintechnik GmbH Emmendingen	2	100%	SU	DE
40	Oculus Optikger?te GmbH Wetzlar	2	100%	OP	DE
41	Adeor Medical AG Valley	2	100%	NE	DE
42	Tomtec Imaging Systems GmbH Unterschleissheim	2	100%	RA	DE
43	3M Espe Dental Products Bavaria D-82228 Seefeld	2	100%	DE	DE
44	Kettenbach GmbH & Co. KG Eschenburg	2	100%	DE	DE
45	Bego Implant Systems GmbH & Co. KG Bremen	2	100%	DE HO	DE
46	Siemens Healthcare Diagnostic Products GmbH Marburg	2	100%	HE IM	DE
47	Aktormed GmbH Barbing	2	100%	SU	DE
48	Maquet GmbH Rastatt	2	100%	HO	DE
49	Eresearchtechnology GmbH Estenfeld	2	100%	AN CV	DE
50	Visus Health IT GmbH Bochum	2	100%	RA	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.