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 7 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Disposable Instruments | 4036LR, B-4036LR | FDA UDI | Class I | Active |
| Disposable Instruments | B-4002A-NS | FDA UDI | Class I | Active |
| Disposable Instruments | 4017S, B-4017S | FDA UDI | Class I | Active |
| Kaiser Permanente Kit Pack | KP-4705-SP, B-KP-4705-SP | FDA UDI | Class I | Active |
| Soft Plug Extended Duration 180 Canalicular Plug | K162361 | FDA 510(k) | U | Active |
| Disposable Cb-Pe Microkeratome Blades | K003820 | FDA 510(k) | Class I | Active |
| Posterior Capsule Shield | K950798 | FDA 510(k) | Class II | Active |
| Disposable M2-Pe Microkeratome Blades | K030401 | FDA 510(k) | Class I | Active |
| Disposable N-Pe Mickrokeratome Blades | K032297 | FDA 510(k) | Class I | Active |
| Npd 1000 Negative Pressure Wound Therapy System | K080275 | FDA 510(k) | Class II | Active |
| Collagen Intracanalicular Plug | K946357 | FDA 510(k) | U | Active |
| Silicone Punctal Plug | K945906 | FDA 510(k) | U | Active |
| Phaco Tips For Phaco Fragmentation Machines | K943379 | FDA 510(k) | Class II | Active |
| Disposable Microkeratome Blades-Pe | K001176 | FDA 510(k) | Class I | Active |
| Softshield(tm) 12, 24, 72 Collagen Corneal Shields | K914529 | FDA 510(k) | Class I | Active |
| Intertip Infusion Set | K934204 | FDA 510(k) | Class II | Active |
| Ophthalmic Sponges | K950241 | FDA 510(k) | Class II | Active |
| Soft Plug Absorbable Plug-Sa | K013613 | FDA 510(k) | U | Active |
| Silicone Punctal Plug | K980437 | FDA 510(k) | U | Active |
| SOFT PLUG Extended Duration 180 Tapered Canalicular Plug | K213988 | FDA 510(k) | U | Active |
| Disposable N-Pe Microkeratome Blades | K022205 | FDA 510(k) | Class I | Active |
| Tonoshield Tonometer Shield | K923877 | FDA 510(k) | Class II | 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 |