Manufacturer registered with FDA
KARL STORZ SE & Co. KG
TUTTLINGEN, Germany. Lists 3 dental device types with FDA across 5 registered establishments, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 11998–1998
- Markets registered in
- 7794 registrations outside the US
- Establishments
- 5Germany, United States
510(k) clearances per year, 1990–2026
Registered in 7 markets
Where regulators' registries name KARL STORZ SE & Co. KG as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | KARL STORZ SE & Co. KG | 1 clearances | 1998–1998 | Below |
| European Union | EUDAMED | Registration holder | KARL STORZ SE & Co. KG | 329 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | KARL STORZ SE & Co. KGKarl Storz SE & Co. KG · KARL STORZ SE & CO. KG | 182 | 2004–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | KARL STORZ SE & CO. KG | 154 | 2003–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | KARL STORZ SE & Co. KG | 63 | 2012–2026 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | KARL STORZ SE & CO. KG | 51 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | KARL STORZ SE & Co. KG | 15 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What KARL STORZ SE & Co. KG currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | Dental Hand Instruments | 2011 |
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Dental Endoscopes | 2007 |
| Surgical Headlight LightEBA · Class 1 | Dental operating lights | Lister | Headlight | 2012 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Karl Storz Endoscopy-America, Inc.FDA reg. 3010202439 | El Segundo, CA, United States | Complaint file establishment |
| KARL STORZ ENDOSCOPY-AMERICA, INC.FDA reg. 2020550 | Auburn, MA, United States | Repacker / relabeler |
| KARL STORZ SE & CO KGFDA reg. 3014342096 | TUTTLINGEN Baden-Wurttemberg, Germany | Specification developer |
| KARL STORZ SE & CO. KGFDA reg. 9610617 | TUTTLINGEN Baden-Wurttemberg, Germany | Contract manufacturer |
| KARL STORZ SE & CO. KGFDA reg. 3010707607 | NEUHAUSEN OBECK Baden-Wurttemberg, Germany | Contract manufacturer |
Other names on FDA records
KARL STORZ Endoscopy-America, Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 8010119). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.