Alpha Omega Services Inc
Bellflower, CA, US
ALPHA-OMEGA SERVICES, INC. appears in FDA device records in Bellflower, CA. FDA records list 9 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 14 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 9 510(k) clearances for Alpha Omega Services Inc between 1997 and 2024. The busiest year on record is 2007, with 4. The most recent is 2024, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 1 |
| 2000 | 1 |
| 2007 | 4 |
| 2011 | 1 |
| 2024 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233628 | AOS Interstitial Templates, Needles, and Accessories | JAQ | Substantially Equivalent | |
| K233626 | AOS Marker Seeds (SMG0242-025) | JAQ | Substantially Equivalent | |
| K102811 | AOS ORION IR-192 SOURCE CABLE | KXK | Substantially Equivalent | |
| K062824 | AOS UNIVERSAL CONECTING GUIDE TUBE | JAQ | Substantially Equivalent | |
| K062823 | AOS INTERSTITIAL TEMPLATES, NEEDLES & ACCESSORIES | JAQ | Substantially Equivalent | |
| K062826 | AOS IMPLANT TUBES, IMPLANT NEEDLES & RETAINING BOTTONS | JAQ | Substantially Equivalent | |
| K062825 | AOS MARKER SEEDS | KXK | Substantially Equivalent | |
| K991571 | 10 CURIE IRDIUM 192, CSN00100-192 | KXK | Substantially Equivalent | |
| K964910 | AOS UNIVERSAL CONNECTING GUIDE TUBE FOR HIGH DOSE RATE AFTERLOADERS | JAQ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2022694 | 2022694 | ALPHA-OMEGA SERVICES, INC. | 9156 ROSE ST, BELLFLOWER, CA 90706 US | 2026 | |
| 3003660614 | 3003660614 | ALPHA-OMEGA SERVICES, INC. | 1282 BIG WOODS-STARK RD., Vinton, LA 70668 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0170-2009 | Alpha-Omega Services, Inc. Product No:NFW0001-010 Description: FLEXIGUIDE NEEDLE, SERIES-15, 25 CM WITHOUT FEMALE LUER ADAPTOR, SHARP AND STYLET WITH 90-DEGREE BEND, 10/PKG Quantity: 10/PKG L-NFW0001-010. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method. | 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. | Terminated | ||
| Z-0169-2009 | Alpha-Omega Services, Inc. Product No:NFW0001-009 Description: FLEXIGUIDE NEEDLE, SERIES-15, 20 CM WITHOUT FEMALE LUER ADAPTOR, SHARP AND STYLET WITH 90-DEGREE BEND, 10/PKG Quantity: 10/PKG L-NFW0001-009. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method. | 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. | Terminated | ||
| Z-0168-2009 | Alpha-Omega Services, Inc. Product No: SPECIAL-NFV Description: CUSTOM FLEXIGUIDE NEEDLE, SERIES 15, WITH FEMALE LUER AND STYLET WITH MALE LUER 28CM, SET OF 100 Quantity: 1/PKG Lot No: K00136 L-SPECIAL- NFV. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method. | 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. | Terminated | ||
| Z-0167-2009 | Alpha-Omega Services, Inc. Product No: NFV0003-003 Description: NEEDLE, FLEXIGUIDE: SERIES-15, 20CM, WITH FEMALE LUER ADAPTOR, SHARP AND STYLET WITH MALE LUER ADAPTOR (HDR); 10/PKG Quantity: 10/PKG L-NFV0003-003. The FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method. | 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. | Terminated | ||
| Z-0166-2009 | 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 FlexiGuide is a flexible needle designed to provide an enclosed pathway for localized radiation therapy using a Remote High Dose Rate (HDR) Afterloader or manual Low Dose Rate (LDR) method. | 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. | Terminated | ||
| Z-0820-06 | VariSource AL13198000, Intralumenal Kit | 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 procedure would have taken place. | Terminated | ||
| Z-0819-06 | KTV0006-002, AOS Tongue And Soft Tissue Kit: AOS Tngue And Soft Tissue Inplant Tubes (20EA); 20CM S.S. Implant Needles, 14 Degrees (20EA) | 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 procedure would have taken place. | Terminated | ||
| Z-0818-06 | VariSource AL 13197000, Tongue/Soft Tissue Kit | 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 procedure would have taken place. | Terminated | ||
| Z-0817-06 | KCV0008-001, AOS Intralumenal Kit: Intralumenal Implant Tubes (5EA) | 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 procedure would have taken place. | Terminated | ||
| Z-0816-06 | VariSource AL 13199024, 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 procedure would have taken place. | Terminated | ||
| Z-0815-06 | TIT0001-003, Implant Tube, Tongue/Soft Tissue, Puthawala/Syed:28cm Leader, 85cm Body, 15cm Draw-Down, Cable Insert, & Nylon Retaining Buttons | 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 procedure would have taken place. | Terminated | ||
| Z-0814-06 | VariSource AL 13199023 Implant Tube, Tongue/Soft Tissue, Puthawala/Syed:28cm Leader, 85cm Body, 15cm Draw-Down, Cable Insert, & Nylon Retaining Buttons: 20/PKG | 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 procedure would have taken place. | Terminated | ||
| Z-0813-06 | 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 procedure would have taken place. | Terminated | ||
| Z-0570-04 | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain