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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 2 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Kaiser Permanente Kit Pack | KP-4716-SP, B-KP-4716-SP | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3827, B-PE3827 | FDA UDI | Class I | Active |
| Disposable Instruments | B-4001A-NS | FDA UDI | Class I | Active |
| Disposable Instruments | 4060 | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3226, B-PE3226 | FDA UDI | Class I | Active |
| Disposable Instruments | 4036F, B-4036F | FDA UDI | Class I | Active |
| Disposable Instruments | 4017A, B-4017A | FDA UDI | Class I | Active |
| Disposable Instruments | 4001AB, B-4001AB | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3720A, B-PE3720A | FDA UDI | Class I | Active |
| Disposable Instruments | 4002H, B-4002H | FDA UDI | Class I | Active |
| Disposable Instruments | 9700, 9700-S | FDA UDI | Class I | Active |
| Disposable Instruments | 4007, B-4007 | FDA UDI | Class I | Active |
| Surgeon's Choice Card | B-SCK 2011 | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3519-SL, B-PE3519-SL | FDA UDI | Class I | Active |
| SOFT PLUG® Silicone Punctum Plug | 6611-S, 6611, 6611-D | FDA UDI | U | Active |
| Disposable Instruments | B-4002B-NSC | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3301, B-PE3301 | FDA UDI | Class I | Active |
| Disposable Instruments | B-4036M-NS | FDA UDI | Class I | Active |
| OASIS® Iris Expander | 9625, 9625-S | FDA UDI | Class I | Active |
| Surgeon's Choice Card | SCK 2007, B-SCK 2007 | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3015, B-PE3015 | FDA UDI | Class I | Active |
| Lacrimal Instruments | 6640 | FDA UDI | Class I | Active |
| Disposable Instruments | 4001, B-4001 | FDA UDI | Class I | Active |
| Surgeon's Choice Card | SCK 2009, B-SCK 2009 | FDA UDI | Class I | Active |
| Disposable Instruments | B-4036-NS | FDA UDI | Class I | Active |
| Disposable Instruments | 4068 | FDA UDI | Class I | Active |
| Disposable Instruments | 4003, B-4003 | FDA UDI | Class I | Active |
| SOFT PLUG® Extended Duration 180 Canalicular Plugs | 6204, 6204-A | FDA UDI | U | Active |
| Disposable Instruments | 4017R, B-4017R | FDA UDI | Class I | Active |
| Disposable Instruments | 4005, B-4005 | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3825, B-PE3825 | FDA UDI | Class I | Active |
| Disposable Instruments | 4017IO, B-4017IO | FDA UDI | Class I | Active |
| Disposable Instruments | 4036P, B-4036P | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE4820-SL, B-PE4820-SL | FDA UDI | Class I | Active |
| Disposable Instruments | 4004C, B-4004C | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3045, B-PE3045 | FDA UDI | Class I | Active |
| Disposable Instruments | 4036LB | FDA UDI | Class I | Active |
| Kaiser Permanente Kit Pack | KP-4703-SP, B-KP-4703-SP | FDA UDI | Class I | Active |
| SOFT PLUG® Extended Duration 180 Tapered Canalicular Plugs | 6210, 6210-A | FDA UDI | U | Active |
| Disposable Instruments | B-4017N-NSC | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE4824-SL, B-PE4824-SL | FDA UDI | Class I | Active |
| Disposable Instruments | 4225 | FDA UDI | Class I | Active |
| Disposable Instruments | 4016AH | FDA UDI | Class I | Active |
| Disposable Instruments | 4004H | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3015-5, B-PE3015-5 | FDA UDI | Class I | Active |
| SOFT SHIELD® Collagen Shields | 7002 | FDA UDI | Class I | Active |
| SOFT PLUG® Silicone Punctum Plug | 7713-FC | FDA UDI | U | Active |
| SOFT SHIELD® Collagen Shields | 7024 | FDA UDI | Class I | Active |
| Disposable Instruments | B-4036LS-NS | FDA UDI | Class I | Active |
| Disposable Instruments | 4017M, B-4017M | 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 |