Data / Medical devices / Netherlands / Amo Groningen BV
Amo Groningen BV: FDA-registered device maker in Groningen, Netherlands, 3 510(k) clearances and 2 PMA approvals
Amo Groningen BV is registered with the FDA (registration 9614546) in Groningen, Netherlands. It lists 6 device types. The FDA files 3 510(k) clearances and 2 PMA approvals under its listings, the newest dated September 13, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9614546
- FEI number
- 3004651700
- Address
- Van Swietenlaan 5, Groningen, Netherlands, 9728 NX
- Owner or operator
- Johnson & Johnson Surgical Vision, Inc. (10053607)
- Roles
- Manufacturer
- First device listed
- December 22, 2016
- Registered through
- 2026
- Brand names listed
- IMPLANT, EYE VALVE, LENS, MULTIFOCAL INTRAOCULAR
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Extended Depth Of Focus Intraocular Lens | POE | 3 | Manufacturer | accessdata.fda.gov |
| Folders And Injectors, Intraocular Lens (Iol) | MSS | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Eye Valve | KYF | 2 | Manufacturer | accessdata.fda.gov |
| Intraocular Lens | HQL | 3 | Manufacturer | accessdata.fda.gov |
| Lens, Intraocular, Toric Optics | MJP | 3 | Manufacturer | accessdata.fda.gov |
| Lens, Multifocal Intraocular | MFK | 3 | 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 |
|---|---|---|---|---|---|---|
| September 13, 2019 | K191949 | UNFOLDER Vitan Inserter | MSS | Substantially Equivalent | Johnson & Johnson Surgical Vision, Inc. | accessdata.fda.gov |
| February 18, 1997 | K955455 | BAERVELT PARS PLANA GLAUCOMA IMPLANT | KYF | Substantially Equivalent | Pharmacia Iovision, Inc. | accessdata.fda.gov |
| February 11, 1991 | K905129 | BAERVELDT GLAUCOMA IMPLANT | KYF | Substantially Equivalent | Wright Medical Corp. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| January 16, 2009 | P080010 | TECNIS MULTIFOCAL FOLDABLE POSTERIOR CHAMBER INTRAOCULAR LENS (IOL) | MFK | 29 | October 19, 2026 | accessdata.fda.gov |
| February 3, 2000 | P980040 | SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS | HQL | 174 | October 19, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Implant, Eye Valve
- All makers of Intraocular Lens
- All makers of Extended Depth Of Focus Intraocular Lens
- All makers of Lens, Multifocal Intraocular
- All makers of Lens, Intraocular, Toric Optics
- All makers of Folders And Injectors, Intraocular Lens (Iol)
Updated October 19, 2026. 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.