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Oasis Medical, Inc.

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
17
Inspections
12
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0522-2016Class IIIHPMC Visoelastic, 20,000 cps, Reference 5122, 515 (Private Label), 600102-001 (Private Label), 60010October 19, 2015
D-0523-2016Class IIIHPMC Visoelastic Topical, 8,000 cps, Reference 5200, 1.5 mL in 3-mL Syringe, OASIS Medical Inc, 514October 19, 2015
D-0524-2016Class IIIHPMC Visoelastic, 8,000 cps, Reference 51082, LT5108 (Private Label), 2.0 mL in 3-mL Syringe, OASIS October 19, 2015
D-1418-2015Class IIIImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 SAugust 31, 2015
D-1084-2015Class IIIImproVue Ophthalmic Lubricant Drops (1.7% Hypromellose), 1 Single Use Syringe, 0.07 fl oz (2mL), 1 SApril 10, 2015
D-1347-2014Class IIIOasis TEARS, Lubricant Eye Drops, 10mL/0.3 fl. oz. Bottle, OTC Only. Distributed by: OASIS, OASIS MeMay 14, 2014

Recent 510(k) Clearances

K-NumberDeviceDate
K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugJune 3, 2022
K162361Soft Plug Extended Duration 180 Canalicular PlugApril 17, 2017
K032297DISPOSABLE N-PE MICKROKERATOME BLADESAugust 26, 2003
K030401DISPOSABLE M2-PE MICROKERATOME BLADESJune 19, 2003
K022205DISPOSABLE N-PE MICROKERATOME BLADESOctober 3, 2002
K013613SOFT PLUG ABSORBABLE PLUG-SAJune 27, 2002
K003820DISPOSABLE CB-PE MICROKERATOME BLADESMarch 8, 2001
K001176DISPOSABLE MICROKERATOME BLADES-PESeptember 21, 2000
K980437SILICONE PUNCTAL PLUGApril 30, 1998
K950798POSTERIOR CAPSULE SHIELDMay 22, 1995
K950241OPHTHALMIC SPONGESFebruary 27, 1995
K946357COLLAGEN INTRACANALICULAR PLUGFebruary 7, 1995
K945906SILICONE PUNCTAL PLUGJanuary 3, 1995
K943379PHACO TIPS FOR PHACO FRAGMENTATION MACHINESOctober 11, 1994
K934204INTERTIP INFUSION SETFebruary 7, 1994
K923877TONOSHIELD TONOMETER SHIELDSeptember 30, 1992
K914529SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDSNovember 13, 1991