8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
W&H 795 TOP AIR TURBINE SINGLE SPRAY
FDA 510(k)
FDA Class 1
·Dental
OXYGEN/AIR TUBING
FDA 510(k)
FDA Class 2
·Anesthesiology
VISC-X VITREOUS ASPIRATING & CUTTING INSTRUMENT SY
FDA 510(k)
FDA Class 2
·Ophthalmic
AU480 CLINICAL CHEMISTRY ANALYZER WITH ISE
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JGS·February 5, 2013
ACCU-CHEK ® AVIVA PLUS TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·July 18, 2014
ALTRUA
FDA Adverse Event
Injury
·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·January 3, 2011
PKG, 5MM INSERT, 45CM, PARK FORCEPS, P/N 0250080745 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
PKG, 5MM INSERT, 45CM, PARK FORCEPS, P/N 0250080745 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