Data / Medical devices / United States / Edm 3, LLC
Edm 3, LLC: FDA-registered device maker in Jacksonville, FL, United States, 1 510(k) clearance
Edm 3, LLC is registered with the FDA (registration 3015909322) in Jacksonville, FL, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated October 28, 1992. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3015909322
- FEI number
- 1000526105
- Address
- 3611 St Johns Bluff Rd S #1, Jacksonville, FL, United States, 32224
- Owner or operator
- EDM 3, LLC (10061440)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- October 18, 2019
- Registered through
- 2027
- Brand names listed
- EDM3 Biopsy Punch
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Manual, Surgical, General Use | MDM | 1 | Manufacturer, Repackager or relabeler | 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 28, 1992 | K921822 | FRAY BIO-PUNCH | MDM | Substantially Equivalent | Fray Products Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| March 18, 2013 | 64888 | Class II | Terminated | HealthLink***BIOPSY PUNCHES*** Disposable manual instrument for skin biopsy. | Due to lack of sterilization. | accessdata.fda.gov |
Compare with other makers
Updated July 2, 2013. 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.