26 results
·
156ms
·
Sources: EU EUDAMED, US FDA
Sterile Safety Hypodermic Needles for Single Use
FDA 510(k)
FDA Class 2
·General Hospital
Sterile Safety Hypodermic Needles for Single Use
FDA 510(k)
FDA Class 2
·General Hospital
Sterile Safety Hypodermic Needles for Single Use
FDA 510(k)
FDA Class 2
·General Hospital
Sterile Safety Hypodermic Needles for Single Use; Sterile Hypodermic Needles for Single Use- Disposable Needles; Sterile Hypodermic Needles for Single Use- Self-sealing Hypodermic Needles
FDA 510(k)
FDA Class 2
·General Hospital
Sterile Safety hypodermic needles for single use
Device
EU MDR
·
Eu Md Class 2a
·Sichuan Prius Biotechnology Co., Ltd·On the market·1 country
Sterile Safety Hypodermic Needles for Single Use
Device
EU MDR
·
Eu Md Class 2a
·Berpu Medical Technology Co., Ltd·On the market·1 country
Sterile Safety Hypodermic Needles for Single Use
Device
EU MDR
·
Eu Md Class 2a
·Shandong Weigao Group Medical Polymer Co., Ltd.·No longer on the market
Self-destruction Safety Syringes for Single Use; Sterile Hypodermic Syringes for Single Use; Sterile Hypodermic Needles for Single Use; Sterile Safety Hypodermic Needles for Single Use
FDA 510(k)
FDA Class 2
·General Hospital
Sterile Safety Syringe with Needle for Single Use, Sterile Safety Hypodermic Needle for Single Use,Sterile Auto-Disable Syringe with Needle for Single Use
FDA 510(k)
FDA Class 2
·General Hospital
DR Safety Syringe, Sterile Hypodermic needle for Single use
FDA 510(k)
FDA Class 2
·General Hospital
Sterile Hypodermic Syringes for Single Use with Safety Needles
FDA 510(k)
FDA Class 2
·General Hospital
Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use
FDA 510(k)
FDA Class 2
·General Hospital
Sterile Safety Hypodermic Needles for Single Use
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Shandong Weigao Group Medical Polymer Co., Ltd.·1 device
Sterile Safety hypodermic needles for single use
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Sichuan Prius Biotechnology Co., Ltd·1 device
Sterile Safety Hypodermic Needles for Single Use
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Berpu Medical Technology Co., Ltd·1 device
Sterile Safety Hypodermic Needles for single use
Basic UDI-DI
EU MDR
·
Eu Md Class 2a
·Shandong Caremed Medical Products Co., Ltd.·26 devices
MONOJECT
FDA Adverse Event
Malfunction
·SOL-MILLENNIUM MEDICAL INC.·Product code FMI·May 16, 2025
BD SAFETYGLIDE SYRINGE W/NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMF·March 25, 2020
Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.
FDA Enforcement
Class II
·Terminated·Smiths Medical ASD Inc.·June 12, 2019
Smith Medical JELCO Hypodermic Needle-Pro EDGE Safety Device Safety Device Rx Only Sterile Product Usage: Is a disposable, single use device intended for injection or aspiration of fluids using a Luer lock or Luer slip syringe. The needle protection device covers the needle after use to help prevent needle sticks.
FDA Recall
Terminated
·Smiths Medical ASD Inc.·Product code FMI·February 11, 2019