7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
Minnesota Medical Technologies Fecal Incontinence Insert (My Miracle)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
GLAID OCULAR ELECTROPHYSIOLOGY DEVICE
FDA 510(k)
FDA Class 2
·Neurology
LineSider Spinal System
FDA 510(k)
FDA Class 2
·Orthopedic
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·November 11, 2014
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Death
·PHILIPS HEALTHCARE - ANDOVER·Product code MKJ·September 7, 2011
PARAGARD
FDA Adverse Event
Injury
·TEVA PHARMACEUTICAL·Product code HDT·July 8, 2013
PKG, ALLIGATOR FORCEPS, P/N 0250080316. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.
FDA Enforcement
Class II
·Terminated·Stryker Endoscopy·December 24, 2014