Data / Medical devices / United States / Dynamic Diagnostics Incorporated
Dynamic Diagnostics Incorporated: FDA-registered device maker in Plymouth, MI, United States, 7 510(k) clearances
Dynamic Diagnostics Incorporated is registered with the FDA (registration 3010230734) in Plymouth, MI, United States. It lists 10 device types. The FDA files 7 510(k) clearances under its listings, the newest dated July 7, 2023. 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
- 3010230734
- Address
- 800 Junction St, Plymouth, MI, United States, 48170
- Owner or operator
- Dynamic Diagnostics Incorporated (10044579)
- Roles
- Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- March 12, 2019
- Registered through
- 2026
- Brand names listed
- Endoscopy Kit, Post Op Eye Kit, Urinalysis Kit
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning Brushes, For Endoscope | MNL | 1 | Specification developer | accessdata.fda.gov |
| Apparatus, Exhaust, Surgical | FYD | 2 | Repackager or relabeler | accessdata.fda.gov |
| Electrosurgical Patient Return Electrode | ODR | 2 | Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Endoscope Channel Accessory | ODC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Endoscopic Bite Block | MNK | 1 | Specification developer | accessdata.fda.gov |
| Endoscopic Irrigation/Suction System | OCX | 2 | Repackager or relabeler | accessdata.fda.gov |
| Kit, Screening, Urine | JXA | 1 | Manufacturer | accessdata.fda.gov |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | HOY | 1 | Manufacturer | accessdata.fda.gov |
| Tray, Biopsy, Without Biopsy Instruments | FCH | 1 | 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 |
|---|---|---|---|---|---|---|
| July 7, 2023 | K230932 | ANDORATE® Valve Kit | OCX | Substantially Equivalent | Ga Health Company Limited | accessdata.fda.gov |
| November 10, 2022 | K223171 | AquaPulse® Irrigation Tubing | OCX | Substantially Equivalent | Ga Health Company Limited | accessdata.fda.gov |
| August 29, 2019 | K192035 | EvaQMax Smoke Evacuation System | FYD | Substantially Equivalent | Bio Protech, Inc. | accessdata.fda.gov |
| July 16, 2015 | K143103 | PROPENCIL Smoke Pencil | GEI | Substantially Equivalent | Bio Protech, Inc. | accessdata.fda.gov |
| December 4, 2009 | K091672 | DISPOSABLE GROUNDING PAD SERIES AND ELECTRODE SERIES | GEI | Substantially Equivalent | Shuyou Electric Medical Science Co., Ltd. | accessdata.fda.gov |
| November 25, 2009 | K092732 | PROPENCIL ESU PENCIL | GEI | Substantially Equivalent | Bio Protech, Inc. | accessdata.fda.gov |
| December 19, 2007 | K073360 | PROPLATE | GEI | Substantially Equivalent | Bio Protech, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Apparatus, Exhaust, Surgical
- All makers of Endoscopic Bite Block
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Kit, Screening, Urine
- All makers of Accessories, Cleaning Brushes, For Endoscope
- All makers of Endoscope Channel Accessory
Updated July 7, 2023. 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.