7 results
·
24ms
·
Sources: EU EUDAMED, US FDA
BOBES TONOMETER
FDA 510(k)
FDA Class 2
·Ophthalmic
MEDITRONIC ANDOVER MEDICAL MODEL 1690 ELECTRODE
FDA 510(k)
FDA Class 2
·Cardiovascular
STRETCH WRAP
FDA 510(k)
FDA Class 1
·General Hospital
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·February 6, 2013
UNKNOWN DEPUY S ROM LINER
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code JDI·December 30, 2010
FENESTRATED BIPOLAR FORCEPS INSTRUMENT
FDA Adverse Event
Malfunction
·INTUITIVE SURGICAL,INC.·Product code NAY·July 21, 2014
PKG, DOLPHIN FORCEPS, SERRATED SPOON, P/N 0250080280. 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