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OASIS Medical, Inc.

US

Last updated September 17, 2026

Information

Country
US
Address
510-528 SOUTH VERMONT AVE., GLENDORA, CA, 91741
Website
—
LinkedIn
—
Facebook
—
Email
—
Phone
—
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
2083373
DUNS Number
—

Catalogue (322)

Page 1 of 7
DeviceModel / ReferenceRegistriesClassStatus
Disposable Instruments B-4017L-NSC
FDA UDI
Class IActive
Disposable Instruments B-4036N-NS
FDA UDI
Class IActive
Premier Edge® Microsurgical Knives PE3818, B-PE3818
FDA UDI
Class IActive
Premier Edge® Microsurgical Knives PE3228, B-PE3228
FDA UDI
Class IActive
Disposable Instruments B-4017G-NS
FDA UDI
Class IActive
Premier Edge® Microsurgical Knives PE3519A, B-PE3519A
FDA UDI
Class IActive
Disposable Instruments B-4008L-NSC
FDA UDI
Class IActive
Premier Edge® Microsurgical Knives PE4828-SL, B-PE4828-SL
FDA UDI
Class IActive
Premier Edge® Microsurgical Knives PE4827-SL, B-PE4827-SL
FDA UDI
Class IActive
SOFT PLUG® Extended Duration 180 Canalicular Plug 6202, 6202-A
FDA UDI
UActive
Disposable Instruments 4001D, B-4001D
FDA UDI
Class IActive
Surgeon's Choice Card SCK 2011
FDA UDI
Class IActive
Disposable Instruments 4028B, B-4028B
FDA UDI
Class IActive
SOFT PLUG® Silicone Punctum Plug 6610-S, 6610, 6610-D
FDA UDI
UActive
Lacrimal lntubation Set 6004
FDA UDI
UActive
Disposable Instruments B-4036-NSC
FDA UDI
Class IActive
SOFT PLUG® Extended Duration 180 Canalicular Plugs 6205, 6205-A
FDA UDI
UActive
Premier Edge® Microsurgical Knives PE4822-SL, B-PE4822-SL
FDA UDI
Class IActive
Disposable Instruments B-4225-NS
FDA UDI
Class IActive
Disposable Instruments B-4028-NSC
FDA UDI
Class IActive
Disposable Instruments 4003-IK
FDA UDI
UActive
Kaiser Permanente Kit Pack KP-4711-SP, B-KP-4711-SP
FDA UDI
Class IActive
Disposable Instruments B-4016G-NSC
FDA UDI
Class IActive
Disposable Instruments B-4017IO-NSC
FDA UDI
Class IActive
Disposable Instruments B-4002F-NSC
FDA UDI
Class IActive
Disposable Instruments B-4002-NS
FDA UDI
Class IActive
Surgeon's Choice Card SCK 1000, B-SCK 1000
FDA UDI
Class IActive
Disposable Instruments 4001F, B-4001F
FDA UDI
Class IActive
Premier Edge® Microsurgical Knives PE3440, B-PE3440
FDA UDI
Class IActive
Disposable Instruments BT-4036A
FDA UDI
Class IActive
Disposable Instruments 4036M, B-4036M
FDA UDI
Class IActive
Kaiser Permanente Kit Pack KP-4710-SP, B-KP-4710-SP
FDA UDI
Class IActive
Disposable Instruments B-4060-NS
FDA UDI
Class IActive
Kaiser Permanente Kit Pack KP-4713-SP, B-KP-4713-SP
FDA UDI
Class IActive
Disposable Instruments B-4001B-NSC
FDA UDI
Class IActive
Premier Edge® Microsurgical Knives PE3525, B-PE3525
FDA UDI
Class IActive
Disposable Instruments B-4017L-NS
FDA UDI
Class IActive
Disposable Instruments B-4036C-NS
FDA UDI
Class IActive
Premier Edge® Microsurgical Knives PE3832, B-PE3832
FDA UDI
Class IActive
Premier Edge® Microsurgical Knives PE4830-SL, B-PE4830-SL
FDA UDI
Class IActive
Surgeon's Choice Card SCK 2002, B-SCK 2002
FDA UDI
Class IActive
Disposable Instruments B-4005-NSC
FDA UDI
Class IActive
SOFT PLUG® Extended Duration Plugs 6400V
FDA UDI
UActive
Disposable Instruments B-4001CTW-NSC
FDA UDI
Class IActive
Disposable Instruments 4017N, B-4017N
FDA UDI
Class IActive
Premier Edge® Microsurgical Knives PE3302, B- PE3302
FDA UDI
Class IActive
SOFT PLUG® Collagen Intracanalicular Plugs A12-102
FDA UDI
UActive
Premier Edge® Microsurgical Knives PE3520, B-PE3520
FDA UDI
Class IActive
Disposable Instruments 6007
FDA UDI
Class IActive
Premier Edge® Microsurgical Knives PE3830, B-PE3830
FDA UDI
Class IActive

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (44)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

DateRecall No.ClassStatusReason
Jul 18, 2007Z-0516-2008—terminated

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

Jul 18, 2007Z-0510-2008—terminated

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

Jul 18, 2007Z-0494-2008—terminated

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

Jul 18, 2007Z-0515-2008—terminated

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

Jul 18, 2007Z-0497-2008—terminated

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

Jul 18, 2007Z-0504-2008—terminated

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

Jul 18, 2007Z-0485-2008—terminated

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

Jul 18, 2007Z-0486-2008—terminated

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

Jul 18, 2007Z-0503-2008—terminated

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

Jul 18, 2007Z-0505-2008—terminated

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

Jul 18, 2007Z-0496-2008—terminated

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

Jul 18, 2007Z-0508-2008—terminated

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

Jul 18, 2007Z-0512-2008—terminated

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

Jul 18, 2007Z-0487-2008—terminated

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

Jul 18, 2007Z-0495-2008—terminated

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

Jul 18, 2007Z-0509-2008—terminated

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

Jul 18, 2007Z-0511-2008—terminated

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

Jul 18, 2007Z-0492-2008—terminated

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

Jul 18, 2007Z-0493-2008—terminated

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

Jul 18, 2007Z-0507-2008—terminated

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

Jul 18, 2007Z-0502-2008—terminated

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

Jul 18, 2007Z-0489-2008—terminated

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

Jul 18, 2007Z-0490-2008—terminated

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

Jul 18, 2007Z-0500-2008—terminated

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

Jul 18, 2007Z-0514-2008—terminated

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

Jul 18, 2007Z-0506-2008—terminated

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

Jul 18, 2007Z-0488-2008—terminated

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

Jul 18, 2007Z-0498-2008—terminated

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

Jul 18, 2007Z-0513-2008—terminated

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

Jul 18, 2007Z-0501-2008—terminated

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

Jul 18, 2007Z-0499-2008—terminated

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

Jul 18, 2007Z-0491-2008—terminated

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

Jun 8, 2007Z-0998-2007—terminated

This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled.

Jun 8, 2007Z-0995-2007—terminated

This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled.

Jun 8, 2007Z-0996-2007—terminated

This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled.

Jun 8, 2007Z-0997-2007—terminated

This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled.

Apr 9, 2007Z-0742-2007—terminated

Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes.

Apr 9, 2007Z-0740-2007—terminated

Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes.

Apr 9, 2007Z-0741-2007—terminated

Plastic shavings are coming from the product handle during irrigation. Use of this product may leave plastic shavings in the patient's eyes.

Jul 6, 2006Z-1520-06—terminated

Labeled with an incorrect diameter

Aug 24, 2005Z-1595-05—terminated

"Please be aware that this is not a new recall. The firm has taken action; but, due to administrative issues additional products are now being classified by the agency". Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators

Aug 24, 2005Z-1601-05—terminated

"Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency". Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators

Aug 24, 2005Z-1600-05—terminated

"Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency". Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators

Aug 24, 2005Z-1599-05—terminated

"Please be aware that this is not a new recall. This recall was initially classified in 2005 (Z-1595-05). The firm has taken action; but, due to administrative issues this product is now being classified by the Agency". Foreign deposit present on the surface of the Vidaurri LASIK Flap Irrigators