Vitreq Bv

FDA Regulatory Profile

Summary

Total Recalls
16
510(k) Clearances
2
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0856-2020Class IIVitreQ 25G Silicone Tipped Cannula-REF: CN25.D01 GTIN: 8719214221522December 17, 2019
Z-0853-2020Class IIVitreQ 27G VFI Cannula-REF: CN27.D03 GTIN: 8719214221461December 17, 2019
Z-0849-2020Class IIVitreQ 23G PFC Injection Needle- Ref: MD23.D01 GTIN: 8719214221362December 17, 2019
Z-0860-2020Class IIVitreQ 25G Blunt Needles with luer-lock connector-REF : CN25.D05 GTIN: 8719214221645December 17, 2019
Z-0855-2020Class IIVitreQ 23G Silicone Tipped Cannula-CN23.D01 GTIN: 8719214221508December 17, 2019
Z-0851-2020Class IIVitreQ 23G VFI Cannula-REF: CN23.D03 GTIN: 8719214221423December 17, 2019
Z-0858-2020Class IIVitreQ 25G Pick Needles-REF: CN25.D04 GTIN: 8719214221607December 17, 2019
Z-0850-2020Class IIVitreQ 25G PFC Injection Needle-Ref: MD25.D01 GTIN: 8719214221386December 17, 2019
Z-0854-2020Class IIVitreQ 20G VFI Cannula-REF: CN20.D03 GTIN: 8719214221485December 17, 2019
Z-0852-2020Class IIVitreQ 25G VFI Cannula-REF: CN25.D03 GTIN: 8719214221447December 17, 2019
Z-0859-2020Class IIVitreQ 23G Blunt Needles with luer-lock connector-REF: CN23.D05 GTIN: 8719214221621December 17, 2019
Z-0857-2020Class IIVitreQ 23G Pick Needles-REF: CN23.D04 GTIN: 8719214221584December 17, 2019
Z-0847-2020Class II(1)VitreQ 25G BF Blunt Needles-BF25.D51 GITN: 8719214221164 (2) VitreQ 25G BF Brush Needles-BF25December 17, 2019
Z-0846-2020Class II(1) VitreQ 23G BF Blunt Needles-BF23.D51 GTIN#: 8719214221126 (2) VitreQ 23G BF Brush Needles-BF23December 17, 2019
Z-0861-2020Class IIVitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:8719214221669December 17, 2019
Z-0848-2020Class II(1) VitreQ 20G BF Blunt Needles-Ref: BF20.D51 GTIN: 8719214221089 (2) VitreQ 20G BF Brush Needles-December 17, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K202038CryoTreQDecember 30, 2020
K182646Vitreq disposable laser probes, light fibers and ChandelierMay 1, 2019