Company · US

Oasis Medical Inc

FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2022. Name variants (Inc, Corp, punctuation) are merged.

17510(k) clearances (0 in 12 months)

44recalls (0 in 12 months)

1recalls that name a 510(k)

Product codes

Code	Device	Records
HNN	Knife, Ophthalmic	36
KYG	Device, Irrigation, Ocular Surgery	7
LZU	Plug, Punctum	7
HNO	Keratome, Ac-Powered	5
HQC	Unit, Phacofragmentation	2
HKY	Tonometer, Manual	1
HOZ	Sponge, Ophthalmic	1
HQE	Instrument, Vitreous Aspiration And Cutting, Ac-Powered	1
MOE	Collagen Corneal Shield	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Jun 3, 2022	K213988	SOFT PLUG Extended Duration 180 Tapered Canalicular Plug Oasis Medical, Inc.	LZU
Apr 17, 2017	K162361	Soft Plug Extended Duration 180 Canalicular Plug Oasis Medical, Inc.	LZU
Aug 26, 2003	K032297	DISPOSABLE N-PE MICKROKERATOME BLADES Oasis Medical, Inc.	HNO
Jun 19, 2003	K030401	DISPOSABLE M2-PE MICROKERATOME BLADES Oasis Medical, Inc.	HNO
Oct 3, 2002	K022205	DISPOSABLE N-PE MICROKERATOME BLADES Oasis Medical, Inc.	HNO
Jun 27, 2002	K013613	SOFT PLUG ABSORBABLE PLUG-SA Oasis Medical, Inc.	LZU
Mar 8, 2001	K003820	DISPOSABLE CB-PE MICROKERATOME BLADES Oasis Medical, Inc.	HNO
Sep 21, 2000	K001176	DISPOSABLE MICROKERATOME BLADES-PE Oasis Medical, Inc.	HNO
Apr 30, 1998	K980437	SILICONE PUNCTAL PLUG Oasis Medical, Inc.	LZU
May 22, 1995	K950798	POSTERIOR CAPSULE SHIELD Oasis Medical, Inc.	HQC
Feb 27, 1995	K950241	OPHTHALMIC SPONGES Oasis Medical, Inc.	HOZ
Feb 7, 1995	K946357	COLLAGEN INTRACANALICULAR PLUG Oasis Medical, Inc.	LZU
Jan 3, 1995	K945906	SILICONE PUNCTAL PLUG Oasis Medical, Inc.	LZU
Oct 11, 1994	K943379	PHACO TIPS FOR PHACO FRAGMENTATION MACHINES Oasis Medical, Inc.	HQC
Feb 7, 1994	K934204	INTERTIP INFUSION SET Oasis Medical, Inc.	HQE
Sep 30, 1992	K923877	TONOSHIELD TONOMETER SHIELD Oasis Medical, Inc.	HKY
Nov 13, 1991	K914529	SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS Oasis Medical, Inc.	MOE

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 3.0mm Thin Slit Knife, Item Code/REF: PE4830-TL; OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE , 2.85mm Thin Slit Knife, Item Code/REF: PE4828-TL; OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 2.75mm Thin Slit Knife, Item Code/REF: PE4827-TL; OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 2.4mm Thin Slit Knife, Item Code/REF: PE 4824-TL; OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 3.2mm Slit Knife; Item Code/REF: PE 3832; OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 3.0mm Slit Knife - Straight Item Code/REF: PE 3830S; OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 3.0mm Slit Knife, Item Code/REF: PE 3830; OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 2.85mm Slit Knife, Item Code/REF: PE 3828; OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 2.75mm Slit Knife, Item Code/REF: PE 3827; OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 2.65mm Slit Knife, Item Code/REF: PE 3826; OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE,2.0mm Angled Crescent Tunnel Knife, Angled, Item Code/REF: PE 3720A; OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 3.0mm Round, Tunnel Knife, Item Code/REF: PE 3630, OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 23g MVR Knife, Item Code/REF: PE3523, OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE ,4.0mm Implant Knife, Item Code/REF: PE 3440; OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 3.5mm Implant Knife, Item Code/REF: PE 3435, OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 3.2mm Implant Knife, Item Code/REF: PE 3432, OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE , 2.5-3.0mm Clear Cornea Knife - Trapezoid, Item Code/REF: PE 3302, OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 3.0mm Clear Cornea Knife - Parallel Sides, Item Code/REF: PE 3230 , OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 2.85mm Clear Cornea Knife - Parallel Sides, Item Code/REF: PE 3228, OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 2.65mm Clear Cornea Knife - Parallel Sides, Item Code/REF: PE 3226; OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 3.2mm Clear Cornea Knife, Item Code/REF: PE 3132, OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 3.0mm Clear Cornea Knife, Item Code/REF: PE 3130; OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 2.85mm Clear Cornea Knife, Item Code/ REF: PE 3128 , OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 2.5mm Clear Cornea Knife, REF/Item Code: PE 3125, OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE, 45 DEGREES STAB KNIFE, REF/Item Code: PE 3045, OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge,MICROSURGICAL KNIFE, 30 DEGREES STAB KNIFE, REF/item Code: PE 3030, OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge, MICROSURGICAL KNIFE,15 DEGREES STAB KNIFE, REF/Item Code: PE 3015, OASIS Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc Eyemaxx your choice!, Microsurgical Knife 3.0mm Slit Knife, REF/Item Code: MX2030, Oasis, Glendora, CA Donawa Consulting Sri Plazza Albania, 10 00153 Rome, Italy MADE IN USA Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc Premier Edge, Bulk Microsurgical Knife, 3.0mm Slit Knife, Item Code B-PE3830, Oasis, Glendora, CA Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc Premier Edge, Bulk Microsurgical Knife. 1.2mm, Sideport Knife, Item Code B-PE3012, Oasis, Gendora, CA Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc PremierEdge MICROSURGICAL KNIFE,1.2mm, Sideport Knife, REF/Item Code: PE 3012, Oasis, Glendora, CA 91741 Terminated	HNN	None listed
Jan 12, 2008	Oasis Medical Inc Disposable Angled MVR Blade (23 gauge/0.6mm), REF/Item Code: 1282D0.6 , OASIS, Glendora, CA. Terminated	HNN	None listed
Jul 4, 2007	Oasis Medical Inc Eyemaxx MVR 20g Microsurgical Knife, Item #MX3020 Terminated	HNN	None listed
Jul 4, 2007	Oasis Medical Inc Premier Edge MVR 20g Microsurgical Knife, Angled, Item PE-3520-A Terminated	HNN	None listed
Jul 4, 2007	Oasis Medical Inc Premier Edge MVR 20g Microsurgical Knife, Item PE-3520 Terminated	HNN	None listed
Jul 4, 2007	Oasis Medical Inc Premier Edge MVR 19g Microsurgical Knife, Item PE-3519 Terminated	HNN	None listed
Jun 27, 2007	Oasis Medical Inc Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1721 Disposable Bimanuals Irrigation/Aspiration Set 21 Gauge, Dual Port; Item #1721-A - Disposable Bimanual Aspiration Handpiece 2 Terminated	KYG	None listed
Jun 27, 2007	Oasis Medical Inc Disposable Bimanuals Irrigation and Aspiration Handpiece Set: Item #1720 Disposable Bimanuals Irrigation/Aspiration Set 20 Gauge, Dual Port; Item #1720-A - Disposable Bimanual Aspiration Handpiece 20g Terminated	KYG	None listed
Jun 27, 2007	Oasis Medical Inc 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 19 Terminated	KYG	None listed
Sep 23, 2006	Oasis Medical Inc OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E) Terminated	LZU	K013613
Oct 1, 2005	Oasis Medical Inc OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification B-4036V-NS, LASIK Flap Irrigator (Vidaurri) The -B4036V-NS cannula is placed into a vacuum formed plastic tray a Terminated	KYG	None listed
Oct 1, 2005	Oasis Medical Inc OASIS Medical Vidaurri LASIK Flap Irrigator, Non-sterilized Bulk, Product Specification MK-036V, LASIK Flap Irrigator (Vidaurri) The MK-03V cannula is placed into a vacuum formed plastic tray and a bl Terminated	KYG	None listed
Oct 1, 2005	Oasis Medical Inc OASIS Medical Vidaurri LASIK Flap Irrigator, Sterilized, Product Specification 8065403604 Dual Tip Irrigator 8 Ports The Dual tip Irrigator 8 Ports is placed into a vacuum formed plastic tray and a Ty Terminated	KYG	None listed
Oct 1, 2005	Oasis Medical Inc 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 eig Terminated	KYG	None listed

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