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Sign in to claim this brandOASIS Medical, Inc.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 510-528 SOUTH VERMONT AVE., GLENDORA, CA, 91741
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 2083373
- DUNS Number
- —
Catalogue (322)
Page 5 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Disposable Instruments | 4036B, B-4036B | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3826, B-PE3826 | FDA UDI | Class I | Active |
| Disposable Instruments | 4017Y | FDA UDI | Class I | Active |
| Disposable Instruments | 4004B, B-4004B | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE4828-TL, B-PE4828-TL | FDA UDI | Class I | Active |
| Disposable Instruments | 4001CF, B-4001CF | FDA UDI | Class I | Active |
| Disposable Instruments | B-4001F-NSC | FDA UDI | Class I | Active |
| Kaiser Permanente Kit Pack | KP-4706-SP, B-KP-4706-SP | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3832S, B-PE3832S | FDA UDI | Class I | Active |
| SOFT PLUG® Silicone Punctum Plug | 7710-S. 7710, 7710-D | FDA UDI | U | Active |
| Premier Edge® Microsurgical Knives | PE3014, B-PE3014 | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3525-SL, B-PE3525-SL | FDA UDI | Class I | Active |
| SOFT PLUG® Silicone Punctum Plug | 7714-S, 7714, 7714-D | FDA UDI | U | Active |
| SOFT PLUG® Extended Duration Plugs | 6405, 6405-A | FDA UDI | U | Active |
| Surgeon's Choice Card | SCK 2004, B-SCK 2004 | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3230, B-PE3230 | FDA UDI | Class I | Active |
| Disposable Instruments | 4016 | FDA UDI | Class I | Active |
| Disposable Instruments | 4036C | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3015-3, B-PE3015-3 | FDA UDI | Class I | Active |
| Disposable Instruments | B-4002-NSC | FDA UDI | Class I | Active |
| SOFT SHIELD® Collagen Shields | 7072 | FDA UDI | Class I | Active |
| SOFT PLUG® Extended Duration Plugs | 504 | FDA UDI | U | Active |
| Disposable Instruments | 4027A, B-4027A | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE4826-TL, B-PE4826-TL | FDA UDI | Class I | Active |
| SOFT PLUG® Silicone Punctum Plug | 7713-S, 7713, 7713-D | FDA UDI | U | Active |
| Premier Edge® Microsurgical Knives | PE4826-SL, B-PE4826-SL | FDA UDI | Class I | Active |
| FORM FIT® Hydrogel Canalicular Plug | 6303, 6303-T, B-6303 | FDA UDI | U | Active |
| PVA Foam Surgical Spear | B-0525 | FDA UDI | Class II | Active |
| Premier Edge® Microsurgical Knives | PE3520-SL | FDA UDI | Class I | Active |
| Disposable Instruments | B-4026-NSC | FDA UDI | Class I | Active |
| SOFT PLUG® Extended Duration Plugs | 503 | FDA UDI | U | Active |
| Premier Edge® Microsurgical Knives | PE3523, B-PE3523 | FDA UDI | Class I | Active |
| Disposable Instruments | 4008, B-4008 | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3452, B-PE3452 | FDA UDI | Class I | Active |
| Disposable Instruments | 4036A, B-4036A | FDA UDI | Class I | Active |
| Disposable Instruments | 4016F | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3523A, B-PE3523A | FDA UDI | Class I | Active |
| Kaiser Permanente Kit Pack | KP-4707-SP, B-KP-4707-SP | FDA UDI | Class I | Active |
| Kaiser Permanente Kit Pack | KP-4712-SP, B-KP-4712-SP | FDA UDI | Class I | Active |
| SOFT PLUG® Collagen Intracanalicular Plugs | A12-103 | FDA UDI | U | Active |
| Premier Edge® Microsurgical Knives | PE3520A-SL, B-PE3520A-SL | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3122, B-PE3122 | FDA UDI | Class I | Active |
| SOFT PLUG® Extended Duration Plugs | 6404, 6404-A | FDA UDI | U | Active |
| Disposable Instruments | 4001AF | FDA UDI | Class I | Active |
| Disposable Instruments | 4027F | FDA UDI | Class I | Active |
| Disposable Instruments | 4036, B-4036 | FDA UDI | Class I | Active |
| Surgeon's Choice Card | SCK 2008, B-SCK 2008 | FDA UDI | Class I | Active |
| Disposable Instruments | 4002F, B-4002F | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE4820-TL, B-PE4820-TL | FDA UDI | Class I | Active |
| Disposable Instruments | 6008 | FDA UDI | Class I | Active |
Related Companies
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Importers
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FDA Recalls (44)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jul 18, 2007 | Z-0516-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0510-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0494-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0515-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0497-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0504-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0485-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0486-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0503-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0505-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0496-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0508-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0512-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0487-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0495-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0509-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0511-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0492-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0493-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0507-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0502-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0489-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0490-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0500-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0514-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0506-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0488-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0498-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0513-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0501-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0499-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jul 18, 2007 | Z-0491-2008 | — | terminated | Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL |
| Jun 8, 2007 | Z-0998-2007 | — | terminated | This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. |
| Jun 8, 2007 | Z-0995-2007 | — | terminated | This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. |
| Jun 8, 2007 | Z-0996-2007 | — | terminated | This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. |
| Jun 8, 2007 | Z-0997-2007 | — | terminated | This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. |
| Apr 9, 2007 | Z-0742-2007 | — | terminated | Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes. |
| Apr 9, 2007 | Z-0740-2007 | — | terminated | Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes. |
| Apr 9, 2007 | Z-0741-2007 | — | terminated | Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes. |
| Jul 6, 2006 | Z-1520-06 | — | terminated | Labeled with an incorrect diameter |
| Aug 24, 2005 | Z-1595-05 | — | terminated | "Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators |
| Aug 24, 2005 | Z-1601-05 | — | terminated | "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency". Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators |
| Aug 24, 2005 | Z-1600-05 | — | terminated | "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency". Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators |
| Aug 24, 2005 | Z-1599-05 | — | terminated | "Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency". Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators |