7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
FLEXIBLE DILATING SHEATH
FDA 510(k)
FDA Class 2
·Cardiovascular
DETECTABUSE(TM)
FDA 510(k)
FDA Class 1
·Clinical Toxicology
RSVP RF-2000
FDA 510(k)
FDA Class 1
·General Hospital
SENSOR ENLITE
FDA Adverse Event
Malfunction
·MEDTRONIC MINIMED·Product code OZO·July 21, 2014
INSIGNIA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 4, 2011
SPECTRUM
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·December 31, 2012
PKG, MARYLAND FORCEPS, CURVED LEFT, P/N 0250080282. 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