8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
INCUBATOR CAPE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
BRIDGE III RECEIVER
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO MARSPO2, MODEL 2001
FDA 510(k)
FDA Class 2
·Cardiovascular
EVIA DR-T
FDA Adverse Event
Injury
·BIOTRONIK SE & CO. KG·Product code DXY·April 8, 2013
NOVA MAX GLUCOSE MONITOR
FDA Adverse Event
Malfunction
·NOVA BIOMEDICAL CORP·Product code NBW·May 9, 2008
VENTAK PRIZM 2
FDA Adverse Event
Malfunction
·GUIDANT CLONMEL IRELAND·Product code LWS·April 6, 2011
Stryker End Cap, Standard T2 Humerus ¿6 mm Catalog Number: 18300003S - Product Usage: Stryker implants are single use devices intended for the temporary fixation, correction or stabilization of bones.
FDA Enforcement
Class II
·Terminated·Stryker GmbH·June 24, 2020
PKG, FIXATION CLAMP 5MM WITH RATCHET, P/N 0250080130 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