Data / Medical devices / United States / MRIMed Inc. DBA: Quality Safety Tools
MRIMed Inc. DBA: Quality Safety Tools: FDA-registered device maker in Petaluma, CA, United States, 2 510(k) clearances
MRIMed Inc. DBA: Quality Safety Tools is registered with the FDA (registration 3009560891) in Petaluma, CA, United States. It lists 11 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 27, 2010. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009560891
- Address
- 1320 Stub Rd, Petaluma, CA, United States, 94954
- Owner or operator
- Quality Safety Tools DBA: MRIMED (10040410)
- Roles
- Repackager or relabeler
- First device listed
- May 5, 2015
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Repackager or relabeler | accessdata.fda.gov |
| Blade, Scalpel | GES | 1 | Repackager or relabeler | accessdata.fda.gov |
| Blood Pressure Cuff | DXQ | 2 | Repackager or relabeler | accessdata.fda.gov |
| Components, Wheelchair | KNN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Device, Medical Examination, Ac Powered | KZF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scalpel, One-Piece | GDX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Stethoscope, Manual | LDE | 1 | Repackager or relabeler | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Repackager or relabeler | accessdata.fda.gov |
| Walker, Mechanical | ITJ | 1 | Repackager or relabeler | 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 27, 2010 | K101892 | HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M- | DXQ | Substantially Equivalent | Heine Optotechnik GmbH & Co. KG | accessdata.fda.gov |
| May 8, 1979 | K790537 | AUTOMATIC ELECTRONIC SPHYMOMONOMETER | DXN | Substantially Equivalent | Healthcare Enterprises, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 13, 2025 | 98127 | Class II | Ongoing | MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in conjunction with SL-110, Mobile Exam Light | Due to battery component overheating while charging resulting in melting of internal components and causing smoke. | accessdata.fda.gov |
Compare with other makers
- All makers of Blade, Scalpel
- All makers of Device, Medical Examination, Ac Powered
- All makers of Scalpel, One-Piece
- All makers of Walker, Mechanical
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Accessory, Surgical Apparel
Updated February 20, 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.