Guangzhou Improve Medical Instruments Co., Ltd.
Guangzhou Guangdong, CN
GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. appears in FDA device records in Guangzhou Guangdong, CN. FDA records list 2 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 2 510(k) clearances for Guangzhou Improve Medical Instruments Co., Ltd. between 2010 and 2016. The busiest year on record is 2010, with 1. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K153388 | IMPROSAFE Blood Collection Set with Pre-attached Holder, IMPROVACUTER Blood Collection Set Pre-attached Holder, IMPROSAFE Blood Collection Set, IMPROVACUTER Blood Collection Set, IMPROSAFE Multi Sample Needle, IMPROSAFE Multi Sample Needle (Flashback), IMPROVACUTER Multi Sample Needle | FMI | Substantially Equivalent | |
| K093910 | IMPROVACUTER GEL & CLOT ACTIVATOR TUBE | JKA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3008449424 | 3008449424 | GUANGZHOU IMPROVE MEDICAL INSTRUMENTS CO., LTD. | No.102, Kaiyuan Avenue, Science City, Guangzhou Economic & Technological Development District, Guangzhou Guangdong 510530 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1217-2019 | Prevent G Safety Winged Blood Collection Set Glide - Rx Only -Sterile/EO - Product Usage: The IMPROSAFE Blood Collection Set is single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. (4) a safety shield, The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood. | Complain due to the hub needle came out when the nurse draw the blood and removed the tube. | Class II | Open, Classified | |
| Z-2549-2018 | Prevent G Safety Winged Blood Collection Set Glide - Sterile/EO | Leaks complaints. | Class II | Open, Classified | |
| Z-2790-2018 | Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood. | Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain