ClearanceBrief
Company ยท US

Vortex Surgical Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2019 to 2022. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)
15recalls (14 in 12 months)
4recalls that name a 510(k)

Product codes

CodeDeviceRecords
HQBPhotocoagulator And Accessories5
MXYCannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal3
HNQHook, Ophthalmic2
HNRForceps, Ophthalmic2
KDDKit, Surgical Instrument, Disposable2
HJKLens, Contact, Polymethylmethacrylate, Diagnostic1
HJMTransilluminator, Ac-Powered1
HMQMarker, Sclera1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Nov 3, 2022K220263Vortex Surgical Laser Probes, Vortex Surgical Illuminated Laser Probes, Vortex Surgical Endoilluminators, Vortex Surgica
Vortex Surgical, Inc.
HQB
Dec 23, 2019K191846MAXReach Laser Probe
Vortex Surgical, Inc.
HQB

Latest recalls

DateFirm and productCodeLinked 510(k)
Feb 4, 2026Vortex Surgical Inc.
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
Open, Classified		 HMQNone listed
Feb 4, 2026Vortex Surgical Inc.
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
Open, Classified		 MXYNone listed
Feb 4, 2026Vortex Surgical Inc.
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
Open, Classified		 HJMNone listed
Feb 4, 2026Vortex Surgical Inc.
Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
Open, Classified		 HNQNone listed
Feb 4, 2026Vortex Surgical Inc.
Vortex Surgical I2 Injection Kit, VS0500
Open, Classified		 KDDNone listed
Feb 4, 2026Vortex Surgical Inc.
Tecfen Retractable Membrane Polisher, QTPR1267-23
Open, Classified		 HNQNone listed
Feb 4, 2026Vortex Surgical Inc.
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
Open, Classified		 MXYNone listed
Feb 4, 2026Vortex Surgical Inc.
Convenience Kits 1. 25GA Convenience Kit - FNX VS0644.25-FNX 2. 25GA Convenience Kit - FXX VS0644.25-FXX 3.25GA Convenience Kit - XES VS0644.25-XES
Open, Classified		 KDDNone listed
Feb 4, 2026Vortex Surgical Inc.
25GA Subretinal Injection Cannula VS0220.25
Open, Classified		 MXYNone listed
Feb 4, 2026Vortex Surgical Inc.
Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744
Open, Classified		 HNRNone listed
Feb 4, 2026Vortex Surgical Inc.
Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5.
Open, Classified		 HQBK220263
Feb 4, 2026Vortex Surgical Inc.
Vortex Surgical 1. 23GA Laser Probe Curved Cat No. VS0120.23 2. 25GA Laser Probe Curved Cat No. VS0120.25 3. 25GA Laser Probe Flex-Tip Cat No. VS0130.25 4. 25GA Laser Probe Illuminated Curved Cat
Open, Classified		 HQBK220263
Feb 4, 2026Vortex Surgical Inc.
Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
Open, Classified		 HJKK050623
Dec 30, 2025Vortex Surgical Inc.
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
Open, Classified		 HQBK220263
Feb 1, 2024Vortex Surgical Inc.
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
Terminated		 HNRNone listed
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