Medical Measurement Systems B.V. FDA Record
Medical Measurement Systems B.V. has 0 FDA recalls, 2 inspections, 7 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Medical Measurement Systems B.V." is on file.
- Latest inspection
- Nov 19, 2015 · OAI
- Latest 510(k)
- Aug 1, 2012
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 7 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 2 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Nov 19, 2015 | Enschede, Netherlands | Devices | Official Action Indicated (OAI) | 3002957361 |
| Nov 8, 2012 | Enschede, Netherlands | Devices | Voluntary Action Indicated (VAI) | 3002957361 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3002957361 | Enschede, Netherlands | 2 | Nov 19, 2015 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K121014 | SOLAR GI | Aug 1, 2012 |
| K071094 | MODIFICATION TO SOLAR GI | Aug 13, 2007 |
| K060166 | OHMEGA | Apr 21, 2006 |
| K052338 | SOLAR GI | Dec 15, 2005 |
| K050993 | MMS VIDEO OPTION | May 26, 2005 |
| K031084 | SOLAR GI SYSTEM | Mar 19, 2004 |
| K031930 | HIGH SPEED EMG MODULE | Mar 3, 2004 |
Medical Measurement Systems B.V. and the FDA: common questions
Has Medical Measurement Systems B.V. received an FDA warning letter?
No FDA warning letter addressed to the name "Medical Measurement Systems B.V." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Medical Measurement Systems B.V. received an FDA Form 483?
FDA has not published a Form 483 for "Medical Measurement Systems B.V." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Medical Measurement Systems B.V.?
The most recent FDA inspection on file ended Nov 19, 2015 at Enschede, Netherlands and was classified OAI. FDA has 2 inspections of Medical Measurement Systems B.V. on file, 1 of them classified OAI (official action indicated).
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