Data / Medical devices / United States / Canady Biotechnology LLC
Canady Biotechnology LLC: FDA-registered device maker in Takoma Park, MD, United States, 5 510(k) clearances
Canady Biotechnology LLC is registered with the FDA (registration 3008849319) in Takoma Park, MD, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 3, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008849319
- Address
- 6930 Carroll Ave, Takoma Park, MD, United States, 20912
- Owner or operator
- US Medical Innovations (10047595)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- January 17, 2011
- Registered through
- 2026
- Brand names listed
- Canady Argon Plasma Probe, Canady Argon Plasma Probes, Canady Helios Cold Plasma XL-1000CP Ablation System, Canady Hybrid Plasma Scalpel, Canady Plasma Electrosurgical Unit & Accessories, Canady Plasma Electrosurgical Unit Series SS601MCA, SS-200E/Canady Plasm Coagulator Argon 2 and Argon 4 with accessories, Canady Plasma Electrosurgical Unit Series SS601MCA, SS-200E/Canady Plasma Coagulator Argon 2 and Argon 4 with acccess., Canady Plasma GIT Probe and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Low Energy Direct Current Thermal Ablation System | OAB | 2 | 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 |
|---|---|---|---|---|---|---|
| May 3, 2024 | K240297 | Canady Helios Cold Plasma XL-1000CP Ablation System (XL-1000CPSYS) | OAB | Substantially Equivalent | Us Medical Innovations, LLC | accessdata.fda.gov |
| November 21, 2019 | K192124 | Canady Plasma SMART XL-1000 Electrosurgical Generator with Accessories | GEI | Substantially Equivalent | Us Medical Innovations, LLC | accessdata.fda.gov |
| December 9, 2011 | K113500 | CANADY VIEIRA HYBRID PLASMA SCALPEL | GEI | Substantially Equivalent | Us Medical Innovations, LLC | accessdata.fda.gov |
| April 6, 2011 | K100669 | CANADY PLASMA ELECTROSURGICAL UNIT SERIES WITH ACCESSORY PROBES AND BLADES | GEI | Substantially Equivalent | Us Medical Innovations, LLC | accessdata.fda.gov |
| August 31, 2005 | K052035 | CANADY PLASMA PROBES | GEI | Substantially Equivalent | Canady Technology, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Low Energy Direct Current Thermal Ablation System
Updated May 3, 2024. 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.