8 results
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19ms
·
Sources: EU EUDAMED, US FDA
PROSTATIC ACID PHOSPHATASE REAGENT TEST/PROSTATIC ACID PHOSPHATASE REAGENT KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NORFLOXACIN 10 MCG SENSI DISC
FDA 510(k)
FDA Class 2
·Microbiology
MATRICS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
PUMP 381 PUMP SET (US)
FDA Adverse Event
Injury
·ABIOMED, INC. - 1220648·Product code OZD·February 19, 2026
SECURA DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·February 15, 2013
PRECISION TEST STRIPS
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE, INC. USA·Product code NBW·January 20, 2011
SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
FDA Adverse Event
Injury
·BAXTER HEALTHCARE CORPORATION·Product code KDJ·July 29, 2014
Marathon Flow Directed Micro Catheter, UltraFlow HPC Flow Directed Micro Catheter Marathon Flow: The device is intended to access periphera and neurovasculature for the controlled selective infusion of physician-specified therapeutics agents such as embolization materials and of diagnostic materials such as contrast media. UltraFlow HPC Flow: The device is intended for the controlled selective infusion of physician-specified pharmacologic agents or contrast media into the distal vasculature of the peripheral and neuroanatomy. It is not intended for use in the coronary vasculature. Catalog No. 105-5055V02 105-5055V02 105-5055V05 105-5065V02 105-5065V05 105-5066V02 105-5066V05
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·November 16, 2016