Oasis Medical, Inc.
Glendora, CA, US
OASIS MEDICAL, INC. appears in FDA device records in Glendora, CA. FDA records list 17 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 44 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Oasis Medical, Inc. between 1991 and 2022. The busiest year on record is 1995, with 4. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1991 | 1 |
| 1992 | 1 |
| 1994 | 2 |
| 1995 | 4 |
| 1998 | 1 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 2 |
| 2003 | 2 |
| 2017 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213988 | SOFT PLUG Extended Duration 180 Tapered Canalicular Plug | LZU | Substantially Equivalent | |
| K162361 | Soft Plug Extended Duration 180 Canalicular Plug | LZU | Substantially Equivalent | |
| K032297 | DISPOSABLE N-PE MICKROKERATOME BLADES | HNO | Substantially Equivalent | |
| K030401 | DISPOSABLE M2-PE MICROKERATOME BLADES | HNO | Substantially Equivalent | |
| K022205 | DISPOSABLE N-PE MICROKERATOME BLADES | HNO | Substantially Equivalent | |
| K013613 | SOFT PLUG ABSORBABLE PLUG-SA | LZU | Substantially Equivalent | |
| K003820 | DISPOSABLE CB-PE MICROKERATOME BLADES | HNO | Substantially Equivalent | |
| K001176 | DISPOSABLE MICROKERATOME BLADES-PE | HNO | Substantially Equivalent | |
| K980437 | SILICONE PUNCTAL PLUG | LZU | Substantially Equivalent | |
| K950798 | POSTERIOR CAPSULE SHIELD | HQC | Substantially Equivalent | |
| K950241 | OPHTHALMIC SPONGES | HOZ | Substantially Equivalent | |
| K946357 | COLLAGEN INTRACANALICULAR PLUG | LZU | Substantially Equivalent | |
| K945906 | SILICONE PUNCTAL PLUG | LZU | Substantially Equivalent | |
| K943379 | PHACO TIPS FOR PHACO FRAGMENTATION MACHINES | HQC | Substantially Equivalent | |
| K934204 | INTERTIP INFUSION SET | HQE | Substantially Equivalent | |
| K923877 | TONOSHIELD TONOMETER SHIELD | HKY | Substantially Equivalent | |
| K914529 | SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS | MOE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2083373 | 2083373 | OASIS MEDICAL, INC. | 510-528 SOUTH VERMONT AVE., GLENDORA, CA 91741 US | 2026 | and 7 more, listed in full below |
| 3006234743 | 2083373 | Oasis Medical, Inc. | 2035 E Financial Way, Glendora, CA 91741 US | 2026 | and 7 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- LZPAid, Surgical, Viscoelastic
- HMXCannula, Ophthalmic
- HOCClip, Iris Retractor
- MOECollagen Corneal Shield
- HNYCystotome
- HNWDilator, Lachrymal
- FRODressing, Wound, Drug
- GENForceps, General & Plastic Surgery
- HNRForceps, Ophthalmic
- HQEInstrument, Vitreous Aspiration And Cutting, Ac-Powered
- HNOKeratome, Ac-Powered
- HNNKnife, Ophthalmic
- OKSLacrimal Stents And Intubation Sets
- FZZMarker, Skin
- GAANeedle, Aspiration And Injection, Disposable
- IMDPack, Hot Or Cold, Disposable
- IMEPack, Hot Or Cold, Reusable
- LZUPlug, Punctum
- HOZSponge, Ophthalmic
- PZGSurgical Eye Tray
- HKYTonometer, Manual
- HQCUnit, Phacofragmentation
Recall records
Showing 25 of 44| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0516-2008 | PremierEdge MICROSURGICAL KNIFE, 3.0mm Thin Slit Knife, Item Code/REF: PE4830-TL; OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0515-2008 | PremierEdge MICROSURGICAL KNIFE , 2.85mm Thin Slit Knife, Item Code/REF: PE4828-TL; OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0514-2008 | PremierEdge MICROSURGICAL KNIFE, 2.75mm Thin Slit Knife, Item Code/REF: PE4827-TL; OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0513-2008 | PremierEdge MICROSURGICAL KNIFE, 2.4mm Thin Slit Knife, Item Code/REF: PE 4824-TL; OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0512-2008 | PremierEdge MICROSURGICAL KNIFE, 3.2mm Slit Knife; Item Code/REF: PE 3832; OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0511-2008 | PremierEdge MICROSURGICAL KNIFE, 3.0mm Slit Knife - Straight Item Code/REF: PE 3830S; OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0510-2008 | PremierEdge MICROSURGICAL KNIFE, 3.0mm Slit Knife, Item Code/REF: PE 3830; OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0509-2008 | PremierEdge MICROSURGICAL KNIFE, 2.85mm Slit Knife, Item Code/REF: PE 3828; OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0508-2008 | PremierEdge MICROSURGICAL KNIFE, 2.75mm Slit Knife, Item Code/REF: PE 3827; OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0507-2008 | PremierEdge MICROSURGICAL KNIFE, 2.65mm Slit Knife, Item Code/REF: PE 3826; OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0506-2008 | PremierEdge MICROSURGICAL KNIFE,2.0mm Angled Crescent Tunnel Knife, Angled, Item Code/REF: PE 3720A; OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0505-2008 | PremierEdge MICROSURGICAL KNIFE, 3.0mm Round, Tunnel Knife, Item Code/REF: PE 3630, OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0504-2008 | PremierEdge MICROSURGICAL KNIFE, 23g MVR Knife, Item Code/REF: PE3523, OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0503-2008 | PremierEdge MICROSURGICAL KNIFE ,4.0mm Implant Knife, Item Code/REF: PE 3440; OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0502-2008 | PremierEdge MICROSURGICAL KNIFE, 3.5mm Implant Knife, Item Code/REF: PE 3435, OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0501-2008 | PremierEdge MICROSURGICAL KNIFE, 3.2mm Implant Knife, Item Code/REF: PE 3432, OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0500-2008 | PremierEdge MICROSURGICAL KNIFE , 2.5-3.0mm Clear Cornea Knife - Trapezoid, Item Code/REF: PE 3302, OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0499-2008 | PremierEdge MICROSURGICAL KNIFE, 3.0mm Clear Cornea Knife - Parallel Sides, Item Code/REF: PE 3230 , OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0498-2008 | PremierEdge MICROSURGICAL KNIFE, 2.85mm Clear Cornea Knife - Parallel Sides, Item Code/REF: PE 3228, OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0497-2008 | PremierEdge MICROSURGICAL KNIFE, 2.65mm Clear Cornea Knife - Parallel Sides, Item Code/REF: PE 3226; OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0496-2008 | PremierEdge MICROSURGICAL KNIFE, 3.2mm Clear Cornea Knife, Item Code/REF: PE 3132, OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0495-2008 | PremierEdge MICROSURGICAL KNIFE, 3.0mm Clear Cornea Knife, Item Code/REF: PE 3130; OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0494-2008 | PremierEdge MICROSURGICAL KNIFE, 2.85mm Clear Cornea Knife, Item Code/ REF: PE 3128 , OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0493-2008 | PremierEdge MICROSURGICAL KNIFE, 2.5mm Clear Cornea Knife, REF/Item Code: PE 3125, OASIS Glendora, CA 91741 | 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 | Terminated | ||
| Z-0492-2008 | PremierEdge MICROSURGICAL KNIFE, 45 DEGREES STAB KNIFE, REF/Item Code: PE 3045, OASIS Glendora, CA 91741 | 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 | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain