6 results
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55ms
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Sources: EU EUDAMED, US FDA
The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g, Product Number 8525.201.
FDA Recall
Open, Classified
·Dutch Ophthalmic USA, Inc.·Product code HQC·May 21, 2019
Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
FDA Recall
Open, Classified
·Dutch Ophthalmic USA, Inc.·Product code HQF·April 14, 2021
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
FDA Recall
Terminated
·Dutch Ophthalmic USA, Inc.·Product code HMX·February 25, 2021
The device is a 25-gauge infusion line that is part of 25-gauge surgical pack labeled TDC Vitrectomy Pack VGPC 25g , Product Number 8525.201.
FDA Enforcement
Class II
·Ongoing·Dutch Ophthalmic USA, Inc.·August 18, 2021
Disposable Replacement Backflush Brush Needles (23 gauge/0.6mm)-for use in vitreoretinal surgery Product Number: labeled as 1281.B1D, product is 1281.B1D06
FDA Enforcement
Class II
·Terminated·Dutch Ophthalmic USA, Inc.·July 28, 2021
Illuminated Stepped Laser Probe Curved-for use in combination with 23G vitrectomy system Product Code: 7510.ALC
FDA Enforcement
Class II
·Ongoing·Dutch Ophthalmic USA, Inc.·July 28, 2021