7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
MERCURY EXPIRATORY RESISTANCE EXERCISER
FDA 510(k)
FDA Class 2
·Anesthesiology
EXA
FDA 510(k)
FDA Class 2
·Radiology
FIBROTEK FIB
FDA 510(k)
FDA Class 2
·Hematology
FR VILLEURBANNE
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·December 22, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·February 5, 2013
INTERSTIM II
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code EZW·July 17, 2014
PKG, 3MM INSERT, ATRAUMATIC GRASPER, SINGLE ACTION, 29CM, P/N 0250282099 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