7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MEDNEXT MICRO-DRILL
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HealthGuard-15
FDA 510(k)
FDA Class 2
·Cardiovascular
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR·Product code CBK·January 21, 2013
M2A MAGNUM MODULAR HEAD
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·December 30, 2010
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·July 18, 2014
PKG, 3MM PEEK MONOPOLAR HANDLE, P/N 0250282045 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