19 results
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39ms
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Sources: EU EUDAMED, US FDA
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FDA Enforcement
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Fortex" Pedicle Screw System Continuous Radius Rod 5.5 - 50mm, X-Spine Systems, Inc., 452 Alexandersville Road Miamisburg, OH 45342 Phone: 937-847-8400
FDA Enforcement
Class II
·Terminated·X Spine Systems Inc·July 1, 2015
Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
FDA Enforcement
Class III
·Terminated·Smiths Medical ASD Inc.·September 26, 2018
Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 4057NP-1, 4067NP-1, 4077EG-1, 4077NP-1, 4084P-1, G1193, G1374, G1585, G1589, G1598, G1621, and G1806. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·February 27, 2019
Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4620P-1, 4640LH, 4640P-1, 4649P-1, 4660EG-1, 4660P-1, 4699LH, 4699P-1, G1325, G1412, G1481, G1509, G1548, G1581, G1586, G1602, G1627, G1632, G1634, G1671, G1675, G1716, G1724, G1773, and G1807. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·February 27, 2019
Vortex Surgical I2 Injection Kit, VS0500
FDA Enforcement
Class II
·Ongoing·Vortex Surgical Inc.·February 11, 2026
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. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327
FDA Enforcement
Class II
·Ongoing·Vortex Surgical Inc.·February 11, 2026
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 VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Cannula-Bulk VS0200.25B 15. 27GA Soft Tip Cannula VS0200.27
FDA Enforcement
Class II
·Ongoing·Vortex Surgical Inc.·February 11, 2026
Tecfen Retractable Membrane Polisher, QTPR1267-23
FDA Enforcement
Class II
·Ongoing·Vortex Surgical Inc.·February 11, 2026
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
FDA Enforcement
Class II
·Ongoing·Vortex Surgical Inc.·February 11, 2026
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
FDA Enforcement
Class II
·Ongoing·Vortex Surgical Inc.·February 11, 2026
Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25;
FDA Enforcement
Class II
·Ongoing·Vortex Surgical Inc.·January 7, 2026
Vortex Surgical TID Pharos Illuminated Depressor, VS0801B
FDA Enforcement
Class II
·Ongoing·Vortex Surgical Inc.·February 11, 2026
Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
FDA Enforcement
Class II
·Ongoing·Vortex Surgical Inc.·February 11, 2026
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27
FDA Enforcement
Class II
·Ongoing·Vortex Surgical Inc.·February 11, 2026
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25
FDA Enforcement
Class II
·Ongoing·Vortex Surgical Inc.·February 11, 2026
25GA Subretinal Injection Cannula VS0220.25
FDA Enforcement
Class II
·Ongoing·Vortex Surgical Inc.·February 11, 2026
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 No. VS0125.25B 5. 25GA Laser Probe MaxReach Cat No. VS0140.25 6. 25GA Laser Probe Straight Cat No. VS0110.25
FDA Enforcement
Class II
·Ongoing·Vortex Surgical Inc.·February 11, 2026
Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
FDA Enforcement
Class II
·Ongoing·Vortex Surgical Inc.·February 11, 2026
Vortex Surgical ACTU8 FORCEPS, 25 GA, ADAPTIVE, REF VS0740.25
FDA Enforcement
Class II
·Terminated·Vortex Surgical Inc.·February 7, 2024