Data / Medical devices / United States / Adept-Med Intl., Inc.
Adept-Med Intl., Inc.: FDA-registered device maker in Diamond Springs, CA, United States, 2 510(k) clearances
Adept-Med Intl., Inc. is registered with the FDA (registration 2918699) in Diamond Springs, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 19, 1987. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2918699
- FEI number
- 3000718212
- Address
- 665 Pleasant Valley Road, Diamond Springs, CA, United States, 95619
- Owner or operator
- ADEPT-MED INTL., INC. (2918699)
- Roles
- Manufacturer
- First device listed
- March 16, 1990
- Registered through
- 2026
- Brand names listed
- FISH
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Retainer, Surgical | GCZ | 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 |
|---|---|---|---|---|---|---|
| March 19, 1987 | K870809 | MCNEALY-GLASSMAN VISCERA RETAINER #3202/3204/3206 | GCZ | Substantially Equivalent | Adept-Med Intl., Inc. | accessdata.fda.gov |
| January 23, 1981 | K802806 | VISECERA RETAINER | GCZ | Substantially Equivalent | Adept-Med Intl., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 17, 2004 | 35406 | Not yet classified | Terminated | Adept-Med brand Glassman Viscera Retainer FISH Sterile, Item Numbers: 3204, 3202, 3203, 3202, 3201, 3200, 3206; Product is manufactured and distributed by Adept-Med International, Inc., 665 Pleasant Valley Rd., Diamond S | Devices for which sterility may be compromised as evidenced by a loss of package integrity. | accessdata.fda.gov |
Compare with other makers
Updated June 22, 2006. 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.