Panels › Ophthalmic › Product code HMX · Class 1
Cannula, Ophthalmic
Regulation 886.4350
0510(k)s in 12 months (77 all time)
0recalls in 12 months (28 all time)
2recalls that name a 510(k)
Top companies in HMX
| Company | 510(k)s | Recalls |
|---|---|---|
| Advanced Surgical Products, Inc. | 29 | 0 |
| Becton Dickinson and Company | 0 | 7 |
| Microsurgical Technology, Inc. | 6 | 0 |
| Vitreq Bv | 0 | 6 |
| Look, Inc. | 5 | 0 |
| Visitec Co. | 3 | 0 |
| Beaver Visitec International, Inc. | 0 | 2 |
| Ellex iScience, Inc. | 0 | 2 |
| Myocure, Inc. | 2 | 0 |
| Storz Instrument Co. | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2025 | Iantrek Inc. Cyclopen Microinterventional Cyclodialysis System. Model Number: CP-300.
Product Description: The CycloPen Microinterventional Cyclodialysis device is a manual surgical instrument used for the ab-int Open, Classified |
HMX | None listed |
| Mar 14, 2024 | Beaver Visitec International, Inc. BVI Visitec Irrigation Handle (20/SP)- Intended to be fit with a cannula for irrigation of the eye
Catalog Number: 581012 Open, Classified |
HMX | None listed |
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office BEAVER-VISITEC INTERNATIONAL, INC. Visitec CANNULA, LASIK IRR (10/BX)BVRVIS
Catalog #585278 Open, Classified |
HMX | None listed |
| Apr 21, 2021 | Anodyne Surgical Hydrodissection Cannula (Chang), 27g, labeled as:
anodynesurgical, REF 7018
ASICO, REF AS-7638
anodynesurgical, REF 7018NS
katena, REF K20-3168
anodynesurgical, REF 104910
MSI, REF CA7800
ACCUTONE, R Terminated |
HMX | None listed |
| Feb 25, 2021 | Dutch Ophthalmic USA, Inc. Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery
Product Number: labeled as 1281.B1D, product is 1281.B1D06 Terminated |
HMX | None listed |
| Dec 17, 2019 | Vitreq Bv VitreQ 25G Silicone Tipped Cannula-REF: CN25.D01
GTIN: 8719214221522 Terminated |
HMX | None listed |
| Dec 17, 2019 | Vitreq Bv VitreQ 23G Silicone Tipped Cannula-CN23.D01
GTIN: 8719214221508 Terminated |
HMX | None listed |
| Dec 17, 2019 | Vitreq Bv VitreQ 20G VFI Cannula-REF: CN20.D03
GTIN: 8719214221485 Terminated |
HMX | None listed |
| Dec 17, 2019 | Vitreq Bv VitreQ 27G VFI Cannula-REF: CN27.D03
GTIN: 8719214221461 Terminated |
HMX | None listed |
| Dec 17, 2019 | Vitreq Bv VitreQ 25G VFI Cannula-REF: CN25.D03
GTIN: 8719214221447 Terminated |
HMX | None listed |
| Dec 17, 2019 | Vitreq Bv VitreQ 23G VFI Cannula-REF: CN23.D03
GTIN: 8719214221423 Terminated |
HMX | None listed |
| Nov 30, 2018 | Beaver Visitec BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in).
The BVI Soft Tip Cannula is intended to irrigate and/or aspirate ophthalmic solutions and liquids in or out of the eye, and remove mater Terminated |
HMX | None listed |
| Jan 11, 2018 | Ellex iScience, Inc. 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. Terminated |
HMX | K080067 |
| Jun 19, 2015 | Hill-Rom, Inc. Steriseal-Cannula Ophthalmic;
Bi-Manual Irrigating/Aspirating Handpiece. Terminated |
HMX | None listed |
| Sep 4, 2014 | Ellex iScience, Inc. iTRACK250A Canaloplasty Microcatheter Kit; Catalogue number: iT-250A; Rx only, sterile.
Indicated for fluid infusion and aspiration during surgery. Terminated |
HMX | K080067 |
| May 27, 2014 | Beaver-Visitec International Inc. Visitec Anterior Chamber Cannula, .40x22mm (27Gx7/8in)
REF 585006
Cannulae are intended to irrigate and or aspirate ophthalmic solutions and liquids in or out of the eye, and remove materials where a Terminated |
HMX | None listed |
| Oct 22, 2013 | Synergetics Inc Synergetics 25 gauge Soft Tip Cannula, packaged in 6 units per box. Catalog number: 30.08.25.
Single-use 25 gauge cannula used in vitreoretinal surgery. Terminated |
HMX | None listed |
| May 10, 2013 | Insight Instruments, Inc. Insight Instruments MIS ( Multi-Port Illumination System)
Illuminated pilot tubes work like a ceiling light while simultaneously protecting the entry sites. Illumination automatically follows the m Terminated |
HMX | None listed |
| Jan 17, 2013 | Bausch and Lomb, Incorporated Bausch and Lomb 27G sterile cannula packed in the Bausch and Lomb Amvisc 1.2% Sodium Hyaluronate ( Model 59051, 59081, 59051L, 59081L) and Amvisc Plus 1.6% Sodium Hyaluronate (Model 60081, 60051, 6005 Terminated |
HMX | None listed |
| May 10, 2011 | Becton Dickinson and Company S5-7606 Silicone Oil injection Cannula 6mm Long - 20G
REF 585247
High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and t Terminated |
HMX | None listed |
| May 10, 2011 | Becton Dickinson and Company S5-7604 Silicone Oil Injection Cannula 4mm Long - 20G
REF 585246
High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera and t Terminated |
HMX | None listed |
| May 10, 2011 | Becton Dickinson and Company BD Visitec
High Viscosity Injector 6mm .90mm (20G) [Hammer]
Catalog Number: 585228
High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed in Terminated |
HMX | None listed |
| May 10, 2011 | Becton Dickinson and Company BD Visitec
High Viscosity Injector 4mm [Hammer] .90 (20G)
Catalog Number: 585208
High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into Terminated |
HMX | None listed |
| May 10, 2011 | Becton Dickinson and Company BD Visitec
High Viscosity Injector 6mm [Hammer] .90mm (20G)
Catalog Number: 585184
High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed in Terminated |
HMX | None listed |
| May 10, 2011 | Becton Dickinson and Company BD Visitec
High Viscosity Injector 4mm .90 (20G) [Hammer]
REF 585173
High Viscosity Injectors are used during retinal surgery for fluid infusion. A High Viscosity Injector is placed into the sclera an Terminated |
HMX | None listed |
| Oct 3, 2008 | Becton Dickinson and Company BD Visitec High Viscosity Injector, 4mm
Ref: 585173. The product is intended for Vitroretinal Surgery. Terminated |
HMX | None listed |
| Aug 25, 2007 | Alcon Research, Ltd Atkinson Retrobulbar Anesthesia Needles, 25 gauge 1 1/2". Catalog Number 8065420920. The product is sold in boxes that contain 10 needles each. Terminated |
HMX | None listed |
| Jan 14, 2004 | Cardinal Health Healon GV, 14 mg per mL, Sodium Hyaluronate, 0.55 ml each, supplied with sterile single-use cannula, Rx only, Manufactured by Pharmacia AB Sweden for Pharmacia & Upjohn Company, A subsidiary of Pharma Terminated |
HMX | None listed |
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