7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
COMFEEL PLUS WOUND DRESSING
FDA 510(k)
FDA Class 1
·General Hospital
TOGGLELOC AND JUGGERLOC IMPLANTS/INSTRUMENTS/KITS
FDA 510(k)
FDA Class 2
·Orthopedic
NEUROGUIDE ANALYSIS SYSTEM
FDA 510(k)
FDA Class 2
·Neurology
HUDSON MICRO MIST NEBULIZER
FDA Adverse Event
Malfunction
·TELEFLEX MEDICAL·Product code CAF·January 16, 2013
UNICEL® DXC 800 SYNCHRON® CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·December 29, 2010
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code MDS·July 17, 2014
PKG, 5MM INSERT, RIGHT ANGLE FORCEP, 45CM P/N 0250080729 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