Gulf Fiberoptics
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000006301
- Devices
- 82
- Registrations
- EUDAMEDFDA
- FDA recalls
- 1
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment, FDA recalls
Catalogue
Search and filter all 82 devicesShowing 1-50 of 82
Company details
- EUDAMED SRN
- US-MF-000006301
- EUDAMED status
- Active
- EUDAMED registered name
- Gulf Fiberoptics
- Registered address
- 448, Commerce Blvd, 34677, Oldsmar, United States
- Website
- www.gulffiberoptics.com
- [email protected]
- Phone
- +1 813 855 6618
- PRRC contact
- Scott Avoy
FDA recalls
2012
- 9 Apr 2012 Z-2029-2012 Class II Terminated The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference.
Full distribution text
- 9 Apr 2012 Z-2029-2012 Class II Terminated The GMF-RC65 Replacement Surgical Headlight Cable for Cogent Microlink falls outside of the firm's 510k due to light transmitting fiber material difference.
FDA establishments
- Gulf Fiberoptics, Inc. OLDSMAR, FL · US FEI 3003768921
From the company website
Gulf Fiberoptics has the largest in-stock selection of ready-to-install flexible endoscope light bundles. Hospitals and clinics demand short lead times for instrument repair and we are here to help. Same day shipping on most bundles. New designs can be made in as little as two days. Let us help your bottom line by having replacement light bundles at your facility when you need them.
Frequently asked questions
How many devices does Gulf Fiberoptics have in the registry?
The registry currently lists 82 devices for Gulf Fiberoptics. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gulf Fiberoptics's devices?
Among its 50 most recently registered devices, Gulf Fiberoptics has devices listed in EUDAMED (7 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Gulf Fiberoptics's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Gulf Fiberoptics's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Gulf Fiberoptics?
FDA recall records list 1 recall initiated by Gulf Fiberoptics, the most recent initiated on 9 Apr 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Gulf Fiberoptics in the registry?
The most recently registered devices listed for Gulf Fiberoptics include Fiber Optic Light Cable, Fiber Optics Light Cable, Surgical Headlight Premium Double Adjustable Headgear and Surgical Headlight.
Which FDA establishments are linked to Gulf Fiberoptics?
1 FDA establishment is linked to Gulf Fiberoptics in the registry; they are listed on the company page.