Data / Medical devices / United Kingdom / GMED Healthcare BV (a Johnson & Johnson Company)
GMED Healthcare BV (a Johnson & Johnson Company): FDA-registered device maker in Leeds, United Kingdom, 1 510(k) clearance
GMED Healthcare BV (a Johnson & Johnson Company) is registered with the FDA (registration 3009421413) in Leeds, United Kingdom. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 22, 2011. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3009421413
- Address
- Capitol Boulevard Capital Park West, Leeds, United Kingdom, LS27 0TS
- Owner or operator
- DePuy Synthes, Inc. (1818910)
- Roles
- Exporter to the US
- First device listed
- July 23, 2015
- Registered through
- 2027
- Brand names listed
- Confidence High Viscosity Spinal Cement
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cement, Bone, Vertebroplasty | NDN | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| December 22, 2011 | K112907 | CONFIDENCE HIGH VISCOSITY SPINAL CEMENT, 16G / 20G | NDN | Substantially Equivalent | Medos International SARL | accessdata.fda.gov |
Compare with other makers
Updated December 22, 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.