Data / Medical devices / United Kingdom / Medivance Instruments Ltd.
Medivance Instruments Ltd.: FDA-registered device maker in HARLESDEN, LONDON London, City of, United Kingdom, 3 510(k) clearances
Medivance Instruments Ltd. is registered with the FDA (registration 3003982003) in HARLESDEN, LONDON London, City of, United Kingdom. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 18, 2011. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3003982003
- Address
- Barretts Green Road, HARLESDEN, LONDON London, City of, United Kingdom, NW10 7AP
- Owner or operator
- MEDIVANCE INSTRUMENTS LTD. (9051184)
- Roles
- Manufacturer
- First device listed
- October 19, 2009
- Registered through
- 2026
- Brand names listed
- Aquacut Quattro AquaCare Twin, AquaCare Single, BAG 45S5, Extra/Xtender & Sprint processor, IntraX processor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Manufacturer | accessdata.fda.gov |
| Airbrush | KOJ | 2 | Manufacturer | accessdata.fda.gov |
| Processor, Radiographic-Film, Automatic | IXW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 18, 2011 | K111167 | XTENDER FILM PROCESSOR, SPRINT FILM PROCESSOR MODEL XTENDER MODEL SPRINT | IXW | Substantially Equivalent | Velopex International, Inc. | accessdata.fda.gov |
| January 6, 2010 | K093503 | INTRAX FILM PROCESSOR | IXW | Substantially Equivalent | Velopex International, Inc. | accessdata.fda.gov |
| October 9, 2003 | K024105 | VELOPEX AQUACUT FLUID ABRASION UNIT | KOJ | Substantially Equivalent | Velopex International, Inc. | accessdata.fda.gov |
Compare with other makers
Updated August 18, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.