8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
JMS AV FISTULA NEEDLE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
MICRO MEDICAL DATA SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CARELINK
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code KRG·June 10, 2014
OMNIPOD INSULIN PUMP
FDA Adverse Event
Malfunction
·INSULET CORPORATION·Product code LZG·November 2, 2012
COMPLETELY PROGRAMMABLE PUMP W/LUER-LOCK TUBING
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS PUERTO RICO·Product code FRN·September 21, 2010
Acidified Concentrate Distribution and Storage-The Isopure ACDS (Acidified Concentrate Distribution and Storage) with remote fill is intended to be used in Hemodialysis facilities for the storage and distribution of acid concentrate to be used in the treatment of Hemodialysis patients Model: ACDS MD704262
FDA Enforcement
Class II
·Terminated·Isopure Corp·September 21, 2022
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012