Contract manufacturerKARL STORZ IMAGING, INC. (Goleta, CA)CaliforniaEar, nose and throatGastroenterology and urologyGeneral and plastic surgeryNeurologyObstetrics and gynecologyOphthalmicRadiologyGeneral hospitalClass IIClass IClass III
KARL STORZ IMAGING, INC.
Contract manufacturer · Goleta, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 2027009 (openFDA record; or search FDA's registration database)
- FEI number
- 2027009
- Registered for
- FDA registration year 2026
- Establishment types
- Manufacturer for export only; Contract manufacturer
- Owner or operator
- KARL STORZ SE & CO KG (FDA owner/operator no. 8010119)
- Registered address
- 1 S Los Carneros Rd, Goleta, CA 93117
- Contract listings
- 38 device listings, 16 product codes, first listed Aug 10, 1999
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Class II | Ear, nose and throat | Contract manufacturing | Mar 6, 2017 |
| FEM | Accessories, Photographic, For Endoscope (Exclude Light Sources) | Class I | Gastroenterology and urology | Contract manufacturing | Mar 15, 2019 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Class II | Gastroenterology and urology | Contract manufacturing | Nov 9, 2007 |
| FGB | Ureteroscope And Accessories, Flexible/Rigid | Class II | Gastroenterology and urology | Contract manufacturing | Dec 26, 2013 |
| FTS | Camera, Cine, Endoscopic, With Audio | Class I | General and plastic surgery | Contract manufacturing | Apr 11, 2013 |
| FWF | Camera, Television, Endoscopic, Without Audio | Class I | General and plastic surgery | Contract manufacturing | Aug 10, 1999 |
| GCJ | Laparoscope, General & Plastic Surgery | Class II | Gastroenterology and urology | Contract manufacturing | Oct 24, 2007 |
| GWG | Endoscope, Neurological | Class II | Neurology | Contract manufacturing | Mar 6, 2017 |
| HET | Laparoscope, Gynecologic (And Accessories) | Class II | Obstetrics and gynecology | Contract manufacturing | Nov 25, 2015 |
| HJO | Biomicroscope, Slit-Lamp, Ac-Powered | Class II | Ophthalmic | Contract manufacturing | Nov 21, 2007 |
| HKI | Camera, Ophthalmic, Ac-Powered | Class II | Ophthalmic | Contract manufacturing | Nov 21, 2007 |
| LLZ | System, Image Processing, Radiological | Class II | Radiology | Contract manufacturing | Apr 11, 2013 |
| LMD | System, Digital Image Communications, Radiological | Class I | Radiology | Contract manufacturing | Nov 25, 2008 |
| OAY | Light Source System, Diagnostic Endoscopic | Class III | Gastroenterology and urology | Contract manufacturing | Sep 16, 2010 |
| OWN | Confocal Optical Imaging | Class II | Gastroenterology and urology | Contract manufacturing | Jun 24, 2016 |
| PYO | Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | Class I | General hospital | Contract manufacturing | Jun 7, 2022 |