Data / Medical devices / United States / Oasis Medical, Inc.
Oasis Medical, Inc.: FDA-registered device maker in Glendora, CA, United States, 10 510(k) clearances
Oasis Medical, Inc. is registered with the FDA (registration 2083373) in Glendora, CA, United States. It lists 17 device types. The FDA files 10 510(k) clearances under its listings, the newest dated June 3, 2022. 5 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2083373
- Address
- South Vermont Ave., Glendora, CA, United States, 91741
- Owner or operator
- OASIS MEDICAL, INC. (2083373)
- Roles
- Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
- First device listed
- October 23, 1995
- Registered through
- 2026
- Brand names listed
- A/C Washout Cannula, Alphachymotrypsin Cannula, Anesthesia Needle, Anterior Chamber Cannula, Capsulorhexis Cystotome, Charleux Cannula, Extend 180 Absorbable Synthetic Implants, FORM FIT Hydrogel Canalicular Plug and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Aid, Surgical, Viscoelastic | LZP | 3 | Contract manufacturer, Manufacturer for export | accessdata.fda.gov |
| Cannula, Ophthalmic | HMX | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Clip, Iris Retractor | HOC | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Collagen Corneal Shield | MOE | 1 | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Cystotome | HNY | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Dilator, Lachrymal | HNW | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Complaint file establishment | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Ophthalmic | HNR | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Knife, Ophthalmic | HNN | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Lacrimal Stents And Intubation Sets | OKS | U | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Marker, Skin | FZZ | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Plug, Punctum | LZU | U | Complaint file establishment, Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Sponge, Ophthalmic | HOZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Surgical Eye Tray | PZG | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 3, 2022 | K213988 | SOFT PLUG Extended Duration 180 Tapered Canalicular Plug | LZU | Substantially Equivalent | Oasis Medical, Inc. | accessdata.fda.gov |
| April 17, 2017 | K162361 | Soft Plug Extended Duration 180 Canalicular Plug | LZU | Substantially Equivalent | Oasis Medical, Inc. | accessdata.fda.gov |
| May 13, 2016 | K160710 | Oasis Lacrimal Intubation Set | OKS | Unknown | Anodyne | accessdata.fda.gov |
| April 28, 2014 | K133542 | PURACYN PLUS SKIN AND WOUND | FRO | Substantially Equivalent | Innovacyn, Inc. | accessdata.fda.gov |
| December 15, 2008 | K082460 | CENEFOM PVA SURGICAL SPEAR | HOZ | Substantially Equivalent | Longtek Scientific Co., Ltd. | accessdata.fda.gov |
| November 16, 2004 | K040912 | HYDROGEL CANALICULAR PLUG | LZU | Substantially Equivalent | Partners IN Biomaterials, Inc. | accessdata.fda.gov |
| June 27, 2002 | K013613 | SOFT PLUG ABSORBABLE PLUG-SA | LZU | Substantially Equivalent | Oasis Medical, Inc. | accessdata.fda.gov |
| April 30, 1998 | K980437 | SILICONE PUNCTAL PLUG | LZU | Substantially Equivalent | Oasis Medical, Inc. | accessdata.fda.gov |
| February 7, 1995 | K946357 | COLLAGEN INTRACANALICULAR PLUG | LZU | Substantially Equivalent | Oasis Medical, Inc. | accessdata.fda.gov |
| November 13, 1991 | K914529 | SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS | MOE | Substantially Equivalent | Oasis Medical, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 18, 2007 | 45870 | Not yet classified | Terminated | Disposable Angled MVR Blade (23 gauge/0.6mm), REF/Item Code: 1282D0.6, OASIS, Glendora, CA. | 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 | accessdata.fda.gov |
| June 8, 2007 | 38130 | Not yet classified | Terminated | Premier Edge MVR 19g Microsurgical Knife, Item PE-3519 | 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. | accessdata.fda.gov |
| April 9, 2007 | 38120 | Not yet classified | Terminated | Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1719 Disposable Bimanuals Irrigation/Aspiration Set 19 Gauge, Dual Port; Item #1719-A - Disposable Bimanual Aspiration Handpiece 19g; Item #1719-I Dispo | Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes. | accessdata.fda.gov |
| July 6, 2006 | 36277 | Not yet classified | Terminated | OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E) | Labeled with an incorrect diameter | accessdata.fda.gov |
| August 24, 2005 | 33431 | Not yet classified | Terminated | OASIS Medical Vidaurri LASIK Flap Irrigator, Product Specification 4036V. The Vidaurri LASIK Flap Irrigator is a 16g x 1/2'' stainless steel cannula with two 25g x 9/16'' tip extensions. There are eight.25mm ports (four | "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 | accessdata.fda.gov |
Compare with other makers
- All makers of Aid, Surgical, Viscoelastic
- All makers of Forceps, General & Plastic Surgery
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Sponge, Ophthalmic
- All makers of Clip, Iris Retractor
- All makers of Cannula, Ophthalmic
Updated June 3, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.