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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 3006234743) 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. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number
3006234743
FEI number
2083373
Address
2035 E Financial Way, Glendora, CA, United States, 91741
Owner or operator
OASIS MEDICAL, INC. (2083373)
Roles
Complaint file establishment, Manufacturer, 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

DeviceProduct codeClassRoleSource
Cannula, OphthalmicHMX1Repackager or relabeleraccessdata.fda.gov
Clip, Iris RetractorHOC1Repackager or relabeleraccessdata.fda.gov
Collagen Corneal ShieldMOE1Repackager or relabeleraccessdata.fda.gov
CystotomeHNY1Repackager or relabeleraccessdata.fda.gov
Dilator, LachrymalHNW1Repackager or relabeleraccessdata.fda.gov
Dressing, Wound, DrugFROURepackager or relabeleraccessdata.fda.gov
Forceps, General & Plastic SurgeryGEN1Repackager or relabeleraccessdata.fda.gov
Forceps, OphthalmicHNR1Repackager or relabeleraccessdata.fda.gov
Knife, OphthalmicHNN1Repackager or relabeleraccessdata.fda.gov
Lacrimal Stents And Intubation SetsOKSURepackager or relabeleraccessdata.fda.gov
Marker, SkinFZZ1Repackager or relabeleraccessdata.fda.gov
Needle, Aspiration And Injection, DisposableGAA1Repackager or relabeleraccessdata.fda.gov
Pack, Hot Or Cold, DisposableIMD1Complaint file establishment, Specification developeraccessdata.fda.gov
Pack, Hot Or Cold, ReusableIME1Repackager or relabeleraccessdata.fda.gov
Plug, PunctumLZUURepackager or relabeleraccessdata.fda.gov
Sponge, OphthalmicHOZ2Manufacturer, Repackager or relabeleraccessdata.fda.gov
Surgical Eye TrayPZG1Repackager or relabeleraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 3, 2022K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugLZUSubstantially EquivalentOasis Medical, Inc.accessdata.fda.gov
April 17, 2017K162361Soft Plug Extended Duration 180 Canalicular PlugLZUSubstantially EquivalentOasis Medical, Inc.accessdata.fda.gov
May 13, 2016K160710Oasis Lacrimal Intubation SetOKSUnknownAnodyneaccessdata.fda.gov
April 28, 2014K133542PURACYN PLUS SKIN AND WOUNDFROSubstantially EquivalentInnovacyn, Inc.accessdata.fda.gov
December 15, 2008K082460CENEFOM PVA SURGICAL SPEARHOZSubstantially EquivalentLongtek Scientific Co., Ltd.accessdata.fda.gov
November 16, 2004K040912HYDROGEL CANALICULAR PLUGLZUSubstantially EquivalentPartners IN Biomaterials, Inc.accessdata.fda.gov
June 27, 2002K013613SOFT PLUG ABSORBABLE PLUG-SALZUSubstantially EquivalentOasis Medical, Inc.accessdata.fda.gov
April 30, 1998K980437SILICONE PUNCTAL PLUGLZUSubstantially EquivalentOasis Medical, Inc.accessdata.fda.gov
February 7, 1995K946357COLLAGEN INTRACANALICULAR PLUGLZUSubstantially EquivalentOasis Medical, Inc.accessdata.fda.gov
November 13, 1991K914529SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDSMOESubstantially EquivalentOasis Medical, Inc.accessdata.fda.gov

Compare with other makers

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.