Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2083373

FEI Number

2083373

Entity Name

OASIS MEDICAL, INC.

City/State/Country

GLENDORA, CA, US

Establishment Address

510-528 SOUTH VERMONT AVE., GLENDORA, CA 91741, US

Establishment Type(s)

Manufacture Device in the United States for Export Only,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

OASIS MEDICAL, INC. (Owner Number: 2083373)

Owner / Operator Contact Address

510-528 SOUTH VERMONT AVENUE, --, Glendora, CA 91741, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Irrigating Cystotome Capsulorhexis Cystotome OASIS Rest & Relief Eye Mask Terry Capsule Polisher Hovis Hydrodissection Cannula Simco Double I/A Cannula Alphachymotrypsin Cannula Tri-Port Subtenon Anesthesia Cannula Charleux Cannula Nucleus Hydrodissection Cannula Simcoe Cortex Extractor Cannula Subtenon Cannula Lin LASIK Cannula Kratz Capsule Polisher LA Labs Anterior Chamber Cannula Anterior Chamber Cannula A/C Washout Cannula Olive Tip Capsule Polisher Kellan Hydrodissection Cannula capsule polisher cortex extractor cannula hydrodissection cannula lasik cannula Irrigating cannula lacrimal cannula infusion cannula SOFT PLUG Extended Duration 180 Tapered Canalicular Plug Oasis TEARS HYPOCHLOROUS Eyelid Cleansing Spray SOFT PLUG Silicone Punctum Plug SOFT PLUG Silicone Punctum Plug, Pen Inserter SOFT PLUG Collagen Intracanalicular Plug SOFT CELL PVA Foam LASIK Shield SOFT CELL PVA Foam WIPE +WICK SOFT CELL LASIK Eye Drain (Chayet), 10mm SOFT CELL LASIK Eye Drain (Chayet/Katzen), 11.5mm SOFT CELL PVA Foam Pledget Anesthesia Needle Peribulbar Needle Retrobulbar Needle PremierEdge Microsurgical Knife Iris Retractor, Single Use Oasis Iris Expander SOFT PLUG Extended Duration Plug Oasis Grooved forceps FORM FIT Hydrogel Canalicular Plug Visco Shield Topical HPMC Viscoelastic ImproVue HPMC Viscoelastic Visco Shield HPMC Viscoelastic

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HNY	Cystotome	Ophthalmic	Class 1	886.4350	1995-10-23
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2016-01-25
HMX	Cannula, Ophthalmic	Ophthalmic	Class 1	886.4350	1995-10-23
LZU	Plug, Punctum	Unknown	Class U	N/A	2022-11-07
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2020-12-21
LZU	Plug, Punctum	Unknown	Class U	N/A	2008-12-01
LZU	Plug, Punctum	Unknown	Class U	N/A	2008-12-01
HOZ	Sponge, Ophthalmic	Ophthalmic	Class 2	886.4790	2018-06-05
GAA	Needle, Aspiration And Injection, Disposable	General, Plastic Surgery	Class 1	878.4800	1995-10-23
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	1998-10-14
HOC	Clip, Iris Retractor	Ophthalmic	Class 1	886.4350	2008-12-01
LZU	Plug, Punctum	Unknown	Class U	N/A	2008-12-01
HNR	Forceps, Ophthalmic	Ophthalmic	Class 1	886.4350	1998-10-14
LZU	Plug, Punctum	Unknown	Class U	N/A	1995-10-23
LZP	Aid, Surgical, Viscoelastic	Ophthalmic	Class 3	886.4275	2008-12-01

Official Correspondent

ISHAN PATIL

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OASIS MEDICAL, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3006234743	Oasis Medical, Inc.	Glendora, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K854401	Microsurgical Technology, Inc.	THE NEW MOBILE TIP MCINTYRE CANNULA	1985-12-30
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30
K842601	Ophthalmic Resources, Inc.	PRE-OPERATIVE OPHTHALMIC DRESSING TRAY	1985-05-10
K781371	Ferris Mfg. Corp.	BONE MARROW ASPIRATION KIT	1978-09-20
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2019	Ellex iScience, Inc.	1	ellex I.Science iTRACK 250A, Canaloplasty Microcatheter Kit, for single use, REF iT-250A, Rx. The firm name on the label is Ellex iScience, Inc., Fremont, CA. Used in ophthalmic surgery.
Z-0022-2009	Becton Dickinson and Company	1	BD Visitec High Viscosity Injector, 4mm Ref: 585173. The product is intended for Vitroretinal Surgery.
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0017-2023	Hobbs Medical, Inc.	1	Hobbs Transbronchial Aspiration Needle and Vacu-lok Aspirating Syringe Catalog Number: 4620

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2083373. Last updated year: 2026. Please use registration number 2083373 when referencing this establishment in official correspondence.