Vision-Sciences, Inc.
United StatesFDA applicant, unverified
- Devices
- 33
- FDA recalls
- 2
At a glance
Market reach
- United States
- FDA recalls
What Vision-Sciences, Inc. makes
Vision-Sciences, Inc. manufactures flexible endoscopes and associated endosheath systems for medical procedures, including nasopharyngolaryngoscopes, cystoscopes, hysteroscopes, bronchoscopes, sigmoidoscopes, and video ENT scopes. Their products incorporate disposable endosheaths designed to reduce cross-contamination and improve hygiene during examinations and interventions. The portfolio also includes video processors for compatible scopes, enabling enhanced imaging capabilities.
The company’s devices are regulated under FDA 510(k) clearance, with products classified as Class I and Class II. These endoscopes and endosheath systems are listed in the FDA’s 510(k) registry, reflecting their authorised status for use in the United States. The manufacturer is based in the US.
Catalogue
Search and filter all 33 devicesFDA recalls
FDA recall records list 2 recalls initiated by Vision-Sciences, Inc., initiated on 2011-12-27. By recorded status: 2 terminated. The reasons filed fall into these groups: electrical or power. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2011
- 27 Dec 2011 Z-0928-2012 Unclassified (pre-2012) Terminated Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged.
- 27 Dec 2011 Z-0929-2012 Unclassified (pre-2012) Terminated Vision-Sciences is recalling the Vision-Sciences Battery Charger due to reports relating to the potential for over-heating and possible burning of the lithium-ion batteries being charged.
Frequently asked questions
How many devices does Vision-Sciences, Inc. have in the registry?
The registry currently lists 33 devices for Vision-Sciences, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vision-Sciences, Inc.'s devices?
Among its 33 most recently registered devices, Vision-Sciences, Inc. has devices listed in FDA 510(k) (33 devices).
What risk classes do Vision-Sciences, Inc.'s devices fall under?
Among its 33 most recently registered devices, the classes recorded for Vision-Sciences, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Vision-Sciences, Inc.?
FDA recall records list 2 recalls initiated by Vision-Sciences, Inc., the most recent initiated on 27 Dec 2011. 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 Vision-Sciences, Inc. in the registry?
The most recently registered devices listed for Vision-Sciences, Inc. include FLEXIBLE NASOPHARYNGO-LARYNGOSCOPE AND ENDOSHEATH, MODIFICATION TO VISION SCIENCES ENDOSHEATH SYSTEM, VISION-SCIENCES CST-2000 FLEXIBLE CYSTOSCOPE WITH SLIDE-ON ENDOSHEATH SYSTEM and VISION-SCIENCES ENT-5000 VIDEO ENT SCOPE WITH ENDOSHEATH TECHNOLOGY, VISION-SCIENCES DPU-5000/DPU-5050 VIDEO PROCESSOR.