KARL STORZ SE & CO KG

Entity profile compiled from public source records

Public Record Profile Registrations: 11 510(k) filings: 1 Recalls: 0

Known Identifiers & Locations

FEI Numbers 1221826, 2020550, 2027009, 3002808268, 3002808273, 3004644065, 3006546082, 3007475226, 3010707607, 3014342096, 3032429484
Owner Operator Numbers 8010119
Locations Covered Auburn, MA, US; CHARLTON, MA, US; El Segundo, CA, US; Franklin, MA, US; Goleta, CA, US; Laagri Harjumaa, EE; NEUHAUSEN OBECK Baden-Wurttemberg, DE; SCHAFFHAUSEN, CH; TUTTLINGEN Baden-Wurttemberg, DE

Registered Establishments (11)

Registration # Establishment Name Location Establishment Type(s) Action
1221826 KARL STORZ ENDOVISION, INC. CHARLTON, MA, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
2020550 KARL STORZ ENDOSCOPY-AMERICA, INC. Auburn, MA, US Repack or Relabel Medical Device View Details
2027009 KARL STORZ IMAGING, INC. Goleta, CA, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3004644065 KARL STORZ VIDEO ENDOSCOPY ESTONIA OUE Laagri Harjumaa, EE Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3006546082 KARL STORZ SE & CO. KG TUTTLINGEN Baden-Wurttemberg, DE Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3010202439 Karl Storz Endoscopy-America, Inc. El Segundo, CA, US Complaint File Establishment per 21 CFR 820.198 View Details
3010707607 KARL STORZ SE & CO. KG NEUHAUSEN OBECK Baden-Wurttemberg, DE Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3014342096 KARL STORZ SE & CO KG TUTTLINGEN Baden-Wurttemberg, DE Develop Specifications But Do Not Manufacture At This Facility View Details
3032429484 KARL STORZ Endovision, Inc. Franklin, MA, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
9610617 KARL STORZ SE & CO. KG TUTTLINGEN Baden-Wurttemberg, DE Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
9614434 STORZ ENDOSKOP PRODUKTIONS GMBH SCHAFFHAUSEN, CH Manufacture Medical Device for Another Party (Contract Manufacturer) View Details

510(k) Premarket Notifications (1)

Submission # Device Name Decision Date Decision Description Action
K254228 KARL STORZ Trocars with Valve Seals 2026-05-11 Substantially Equivalent View Details

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

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