Guangzhou Improve Medical Instruments Co., Ltd.

FDA Regulatory Profile

Guangzhou Improve Medical Instruments Co., Ltd. appears in FDA public data with 3 recalls, 2 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1217-2019, Class II) was initiated on September 22, 2017. Its most recent 510(k) clearance was granted on June 7, 2016.

Summary

Total Recalls
3
510(k) Clearances
2
Inspections
2
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1217-2019Class IIPrevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSSeptember 22, 2017
Z-2549-2018Class IIPrevent G Safety Winged Blood Collection Set Glide - Sterile/EOSeptember 22, 2017
Z-2790-2018Class IIImprove Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: TheOctober 19, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K153388IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attacJune 7, 2016
K093910IMPROVACUTER GEL & CLOT ACTIVATOR TUBEJuly 12, 2010