Data / Medical devices / United States / Alpha-Omega Services, Inc.
Alpha-Omega Services, Inc.: FDA-registered device maker in Bellflower, CA, United States, 3 510(k) clearances
Alpha-Omega Services, Inc. is registered with the FDA (registration 2022694) in Bellflower, CA, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 10, 2024. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2022694
- Address
- 9156 Rose ST, Bellflower, CA, United States, 90706
- Owner or operator
- ALPHA-OMEGA SERVICES (2022694)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- November 29, 2007
- Registered through
- 2026
- Brand names listed
- AOS Interstitial Templates, Needles, and Accessories, AOS Marker Seeds, Universal Connecting Guide Tube
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Source, Brachytherapy, Radionuclide | KXK | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| July 10, 2024 | K233628 | AOS Interstitial Templates, Needles, and Accessories | JAQ | Substantially Equivalent | Alpha-Omega Services, Inc. | accessdata.fda.gov |
| July 2, 2024 | K233626 | AOS Marker Seeds (SMG0242-025) | JAQ | Substantially Equivalent | Alpha-Omega Services, Inc. | accessdata.fda.gov |
| March 10, 1997 | K964910 | AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS | JAQ | Substantially Equivalent | Alpha-Omega Services, 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 |
|---|---|---|---|---|---|---|
| November 15, 2007 | 49128 | Not yet classified | Terminated | Alpha-Omega Services, Inc. Product No: NFV0001-004 Description: NEEDLE, FLEXIGUIDE: SERIES-15, 25CM, WITH FEMALE LUER ADAPTOR, SHARP AND STYLET WITH MALE LUER ADAPTOR (HDR); 10/PKG Quantity: 10/PKG L-NFV0001-004. The Fle | There is a possibility that the Flexiguide Needle tip is defective. There is the potential for the needles tip to leak, thereby breaking the sterile boundary and possibly contaminating other devices with body fluids. | accessdata.fda.gov |
| February 21, 2006 | 34969 | Not yet classified | Terminated | TII0002 Implant Tube, Implant Tube, Intralumenal(HDR), 10CM Drawdown 130CM Body, Sealed End, Cable Insert & Gold Seed, Disposable | There is a possibility that the diameter of the catheter does not meet specifications. As a result it may not be possible to correctly connect the catheter to a VariSource Quick Connect. This would prevent any treatment. Furthermore, since the problem would not be apparent until after the catheter has been implanted an unnecessary surgical implantation proce | accessdata.fda.gov |
| September 4, 2003 | 27709 | Not yet classified | Terminated | Template Needle, Series 17, 20 cm, with Threaded Female hub and Bent Stylet, Closed-End, Disposable. Packaged in single, 10, 15, 20 per package. | Template needle may fracture leaving tip in patient. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Applicator, Radionuclide, Remote-Controlled
- All makers of Source, Brachytherapy, Radionuclide
Updated July 10, 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.