8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
SHERWOOD MEDICAL ARTERIAL BLOOD GAS KIT I
FDA 510(k)
FDA Class 1
·Anesthesiology
CRYSTAL FOCUS EMERALD LASER/SLT OPHF 0.6 ENDO HAND
FDA 510(k)
FDA Class 2
·Ophthalmic
SHIMADZU IMAGE AMPLIFIER IA-9LM SERIES
FDA 510(k)
FDA Class 2
·Radiology
INTERGRATED APD SET
FDA Adverse Event
Malfunction
·VANTIVE US HEALTHCARE LLC·Product code FKX·April 4, 2025
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·January 22, 2013
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 14, 2010
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 10, 2014
Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The GYNECARE THERMACHOICE III Uterine Balloon Therapy (UBT) System is a thermal balloon ablation device intended to ablate the endometrial lining of the uterus in pre-menopausal women with menorrhagia (excessive uterine bleeding) due to benign causes for whom childbearing is complete.
FDA Recall
Terminated
·Ethicon, Inc. US·Product code PFJ·December 3, 2015