Is this your brand? Sign in to claim ownership.
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 4 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Premier Edge® Microsurgical Knives | PE4815-SL, B-PE4815-SL | FDA UDI | Class I | Active |
| Disposable Instruments | 4017G, B-4017G | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3720, B-PE3720 | FDA UDI | Class I | Active |
| Kaiser Permanente Kit Pack | KP-4708-SP, B-KP-4708-SP | FDA UDI | Class I | Active |
| SOFT PLUG® Extended Duration Plug, 0.3mm DIA x 2mm Long | 6403, 6403-A | FDA UDI | U | Active |
| SOFT PLUG® Extended Duration Plugs | 505 | FDA UDI | U | Active |
| Premier Edge® Microsurgical Knives | PE3227, B-PE3227 | FDA UDI | Class I | Active |
| Disposable Instruments | 4027, B-4027 | FDA UDI | Class I | Active |
| Disposable Instruments | 4036N, B-4036N | FDA UDI | Class I | Active |
| Lacrimal lntubation Set | 6002 | FDA UDI | U | Active |
| Surgeon's Choice | KP-4003-SP, B-KP-4003-SP | FDA UDI | Class I | Active |
| Disposable Instruments | 4300P | FDA UDI | Class I | Active |
| SOFT PLUG® Silicone Punctum Plug | 6610-EP | FDA UDI | U | Active |
| Disposable Instruments | 4004 | FDA UDI | Class I | Active |
| Disposable Instruments | 4028, B-4028 | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3022, B-PE3022 | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE4832-SL, B-PE4832-SL | FDA UDI | Class I | Active |
| Lacrimal Instruments | 6627 | FDA UDI | Class I | Active |
| Disposable Instruments | 4017Z | FDA UDI | Class I | Active |
| Disposable Instruments | 4036G | FDA UDI | Class I | Active |
| Disposable Instruments | 4002A, B-4002A | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3828, B-PE3828 | FDA UDI | Class I | Active |
| SOFT SHIELD® Collagen Shields | 7012 | FDA UDI | Class I | Active |
| Disposable Instruments | 4002L, B-4002L | FDA UDI | Class I | Active |
| Disposable Instruments | BT-4036D | FDA UDI | Class I | Active |
| Disposable Instruments | 4004D, B-4004D | FDA UDI | Class I | Active |
| Disposable Instruments | B-4017G-NSC | FDA UDI | Class I | Active |
| Disposable Instruments | B-4005TP-NSC | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3128-SL, B-PE3128-SL | FDA UDI | Class I | Active |
| Disposable Instruments | 4029A | FDA UDI | Class I | Active |
| SOFT PLUG® Collagen Intracanalicular Plugs | 6504, B-6504 | FDA UDI | U | Active |
| SOFT PLUG® Silicone Punctum Plug | 6614-SFC, 6614-FC | FDA UDI | U | Active |
| Lacrimal lntubation Set | 6004-27 | FDA UDI | U | Active |
| Disposable Instruments | 4002B, B-4002B | FDA UDI | Class I | Active |
| SOFT PLUG® Extended Duration Plugs | 6402, 6402-A | FDA UDI | U | Active |
| Lacrimal Instruments | 6625 | FDA UDI | Class I | Active |
| Disposable Instruments | B-4036P-NSC | FDA UDI | Class I | Active |
| Disposable Instruments | 4017, B-4017 | FDA UDI | Class I | Active |
| Disposable Instruments | 4017IS, B-4017IS | FDA UDI | Class I | Active |
| Lacrimal Instruments | 6648 | FDA UDI | Class I | Active |
| Surgical Marking Pen | 0442 | FDA UDI | Class I | Active |
| SOFT PLUG® Silicone Punctum Plug | 7711-S, 7711, 7711-D | FDA UDI | U | Active |
| Kaiser Permanente Kit Pack | KP-4709-SP, B-KP-4709-SP | FDA UDI | Class I | Active |
| Surgeon's Choice Card | SCK 2005, B-SCK 2005 | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE3126, B-PE3126 | FDA UDI | Class I | Active |
| Disposable Instruments | 4016G, B-4016G | FDA UDI | Class I | Active |
| Disposable Instruments | B-4017M-NS | FDA UDI | Class I | Active |
| Kaiser Permanente Kit Pack | KP-4704-SP, B-KP-4704-SP | FDA UDI | Class I | Active |
| Premier Edge® Microsurgical Knives | PE4832-TL, B-PE4832-TL | FDA UDI | Class I | Active |
| SOFT PLUG® Silicone Punctum Plug | 6611-EP | FDA UDI | U | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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 |