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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 3 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Disposable Instruments | 4017X, B-4017X | FDA UDI | Class I | Active |
| Disposable Instruments | B-4036J-NS | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3125, B-PE3125 | FDA UDI | Class I | Active |
| Disposable Instruments | B-4001-NS | FDA UDI | Class I | Active |
| Disposable Instruments | 4042-4S | FDA UDI | Class I | Active |
| Disposable Instruments | BT-4002 | FDA UDI | Class I | Active |
| SOFT PLUG® Silicone Punctum Plug | 7714-FC | FDA UDI | U | Active |
| Premier Edge® Microsurgical Knives | PE3010-SL, B-PE3010-SL | FDA UDI | Class I | Active |
| Disposable Instruments | B-4017R-NSC | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3519, B-PE3519 | FDA UDI | Class I | Active |
| Disposable Instruments | B-4002L-NSC | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE4827-TL, B-PE4827-TL | FDA UDI | Class I | Active |
| Disposable Instruments | 4001B | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3012, B-PE3012 | FDA UDI | Class I | Active |
| Disposable Instruments | B-4002F-NS | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3030, B-PE3030 | FDA UDI | Class I | Active |
| Disposable Instruments | B-4002L-NS | FDA UDI | Class I | Active |
| SOFT PLUG® Silicone Punctum Plug | 7712-S, 7712, 7712-D | FDA UDI | U | Active |
| Disposable Instruments | 4026, B-4026 | FDA UDI | Class I | Active |
| Disposable Instruments | B-4017M-NSC | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE4830-TL, B-PE4830-TL | FDA UDI | Class I | Active |
| Lacrimal Instruments | 6643 | FDA UDI | Class I | Active |
| Disposable Instruments | 4036L | FDA UDI | Class I | Active |
| Kaiser Permanente Kit Pack | KP-4715-SP, B-KP-4715-SP | FDA UDI | Class I | Active |
| Disposable Instruments | B-4027-NS | FDA UDI | Class I | Active |
| Surgeon's Choice Card | SCK 2001, B-SCK 2001 | FDA UDI | Class I | Active |
| Disposable Instruments | 4004M | FDA UDI | Class I | Active |
| Disposable Instruments | B-4017IE-NSC | FDA UDI | Class I | Active |
| SOFT PLUG® Collagen Canalicular Plugs | 6200V | FDA UDI | U | Active |
| SOFT PLUG® Silicone Punctum Plug | 7700 | FDA UDI | U | Active |
| Disposable Instruments | 4008L, B-4008L | FDA UDI | Class I | Active |
| SOFT PLUG® Extended Duration 180 Plugs | 6203, 6203-A | FDA UDI | U | Active |
| Disposable Instruments | 4036LS | FDA UDI | Class I | Active |
| SOFT SHIELD® Collagen Shields | 7172 | FDA UDI | Class I | Active |
| Disposable Instruments | B-4002B-NS | FDA UDI | Class I | Active |
| Disposable Instruments | 6010 | FDA UDI | Class I | Active |
| SOFT PLUG® Collagen Intracanalicular Plugs | 6503, B-6503 | FDA UDI | U | Active |
| SOFT PLUG® Silicone Punctum Plug | 6612-EP | FDA UDI | U | Active |
| Disposable Instruments | 4027B | FDA UDI | Class I | Active |
| SOFT PLUG® Silicone Punctum Plug | 7712-FC | FDA UDI | U | Active |
| Disposable Instruments | B-4001AF-NSC | FDA UDI | Class I | Active |
| Disposable Instruments | B-4036N-NSC | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3824, B-PE3824 | FDA UDI | Class I | Active |
| Lacrimal Instruments | 6630 | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3630, B- PE3630 | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3010, B-PE3010 | FDA UDI | Class I | Active |
| SOFT CELL® PVA Foam Surgical Spears | 0525, 0525-A | FDA UDI | Class II | Active |
| Premier Edge® Microsurgical Knives | PE4824-TL, B-PE4824-TL | FDA UDI | Class I | Active |
| Disposable Instruments | B-4036J-NSC | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3015-SL, B-PE3015-SL | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
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Notified Bodies
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Authorities
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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 |