7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
LACTATE REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9)
FDA 510(k)
FDA Class 2
·Cardiovascular
Vivo 1, Vivo 2
FDA 510(k)
FDA Class 2
·Anesthesiology
INTERMATE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code FRN·May 30, 2014
M2A-MAGNUM PF CUP 50ODX44ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·November 20, 2012
SPRINT FIDELIS
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·September 22, 2010
PKG, 5MM INSERT, HOOK SCISSORS, 45CM, P/N 0250080573 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