Emed Technologies Corporation
El Dorado Hills, CA, US
EMED TECHNOLOGIES CORPORATION appears in FDA device records in El Dorado Hills, CA. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Emed Technologies Corporation between 2012 and 2025. The busiest year on record is 2014, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2012 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2022 | 2 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K251105 | Tetra (TM-20); Tetra (TM-50) | PKP | Substantially Equivalent | |
| K240148 | SCIg60 Infusion System | PKP | Substantially Equivalent | |
| K230883 | VersaPump Infusion System | PKP | Substantially Equivalent | |
| K213429 | AccuSert Needle Inserter | KZH | Substantially Equivalent | |
| K222087 | SCIg60 Infusion System | PKP | Substantially Equivalent | |
| K173783 | SCIg60 Infusion System | PKP | Substantially Equivalent | |
| K161906 | SCIg60 Infuser | PKP | Substantially Equivalent | |
| K142319 | SCIg60 Infuser, Infuset | PKP | Substantially Equivalent | |
| K140133 | INFUSET FLOW CONTROL EXTENSION SET | FPA | Substantially Equivalent | |
| K140131 | SUB-Q SUBCUTANEOUS TISSUE INFUSION SET | FPA | Substantially Equivalent | |
| K123729 | VERSARATE FLOW RATE CONTROLER | FPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2523167 | 2523167 | EMED TECHNOLOGIES CORPORATION | 1262 Hawks Flight Ct Ste 200, EL DORADO HILLS, CA 95762 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain