Data / Medical devices / United States / Apex Medical Technologies, Inc.
Apex Medical Technologies, Inc.: FDA-registered device maker in San Diego, CA, United States, 2 510(k) clearances
Apex Medical Technologies, Inc. is registered with the FDA (registration 2025773) in San Diego, CA, United States. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 5, 1996. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2025773
- Address
- 10064 Mesa Ridge Ct Ste 202, San Diego, CA, United States, 92121
- Owner or operator
- APEX MEDICAL TECHNOLOGIES, INC. (2025773)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer
- First device listed
- October 5, 1992
- Registered through
- 2026
- Brand names listed
- EndosacTM Seamless Specimen Collection Pouch, Hy-geneTM Seminal Fluid Collection Kit, Male-FactorPakTM
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condom | HIS | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Device, Specimen Collection | LIO | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Dilator, Vessel, Surgical | DWP | 2 | Contract manufacturer | accessdata.fda.gov |
| Endoscopic Ultrasound System, Gastroenterology-Urology | ODG | 2 | Contract manufacturer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Contract 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 |
|---|---|---|---|---|---|---|
| January 5, 1996 | K954791 | SEMINAL FLUID COLLECTION KIT II | HIS | Substantially Equivalent | Apex Medical Technologies, Inc. | accessdata.fda.gov |
| March 18, 1993 | K930313 | APEX SPECIMEN BAG | LIO | Substantially Equivalent | Apex Medical Technologies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Endoscopic Ultrasound System, Gastroenterology-Urology
- All makers of Dilator, Vessel, Surgical
- All makers of Container, Specimen, Sterile
- All makers of Condom
- All makers of Device, Specimen Collection
Updated January 5, 1996. 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.