Data / Medical devices / United States / Em Innovations, Inc.
Em Innovations, Inc.: FDA-registered device maker in Galloway, OH, United States, 1 510(k) clearance
Em Innovations, Inc. is registered with the FDA (registration 1529990) in Galloway, OH, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 14, 1988. 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
- 1529990
- FEI number
- 1000515375
- Address
- 6106 Bausch Road, Galloway, OH, United States, 43119
- Owner or operator
- EM INNOVATIONS, INC. (9008120)
- Roles
- Specification developer
- First device listed
- November 14, 2007
- Registered through
- 2026
- Brand names listed
- Suction Easy
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheters, Suction, Tracheobronchial | BSY | 1 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| July 14, 1988 | K882017 | RESPIRONICS SUCTIONEASY | BSY | Substantially Equivalent | Respironics, 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 |
|---|---|---|---|---|---|---|
| April 3, 2006 | 36165 | Not yet classified | Terminated | Model EMI 82691, Stic Kit Needle Containment Device. These devices are packaged 60 per case. Stick-on label on device and User Instruction sheet are attached to the case with a rubber band. | The firm failed to include User Instructions with the Stic Kit Needle Containment Device, Model EMI 82691, which they shipped to distributor/customers. | accessdata.fda.gov |
Compare with other makers
Updated October 20, 2006. 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.