8 results · 19ms · Sources: EU EUDAMED, US FDA

Get notified when this changes

We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

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