Data / Medical devices / United States / TOMY International
TOMY International: FDA-registered device maker in Dyersville, IA, United States, 2 510(k) clearances
TOMY International is registered with the FDA (registration 3006852457) in Dyersville, IA, United States. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated October 9, 2008. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3006852457
- Address
- 2021 9TH ST. S.E., Dyersville, IA, United States, 52040
- Owner or operator
- TOMY International, Inc. (9086544)
- Roles
- Complaint file establishment
- First device listed
- July 30, 2015
- Registered through
- 2026
- Brand names listed
- Dispenser, Liquid Medication, Liquid Filled Teether, Manual Toothbrush, Multi-Use Digital Thermometer, P17498 Gel Pack, Quiet Expressions Breast Pump, Sunscreen Applicator, TEETHER and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applicator, Absorbent Tipped, Non-Sterile | KXF | 1 | Complaint file establishment | accessdata.fda.gov |
| Continuous Measurement Thermometer | FLL | 2 | Complaint file establishment | accessdata.fda.gov |
| Dispenser, Liquid Medication | KYX | 1 | Complaint file establishment | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Complaint file establishment | accessdata.fda.gov |
| Ring, Teething, Fluid-Filled | KKO | 2 | Complaint file establishment | accessdata.fda.gov |
| Ring, Teething, Non-Fluid Filled | MEF | 1 | Complaint file establishment | accessdata.fda.gov |
| Toothbrush, Manual | EFW | 1 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| October 9, 2008 | K082802 | MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B | HGX | Substantially Equivalent | Learning Curve Brands Inc. the First Years | accessdata.fda.gov |
| May 23, 1985 | K851146 | DIGITAL THERMOMETER | FLL | Substantially Equivalent | Micro Idea Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Applicator, Absorbent Tipped, Non-Sterile
- All makers of Ring, Teething, Non-Fluid Filled
- All makers of Continuous Measurement Thermometer
- All makers of Ring, Teething, Fluid-Filled
- All makers of Pump, Breast, Powered
- All makers of Dispenser, Liquid Medication
Updated October 9, 2008. 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.