7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
3M XP-2000 X-RAY FILM PROCESSOR
FDA 510(k)
FDA Class 2
·Radiology
MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING
FDA 510(k)
FDA Unclassified
·Unknown
PROCTIGARD
FDA 510(k)
FDA Unclassified
·Unknown
OCTRODE
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·June 18, 2014
R SERIES DEFIBRILLATOR
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·December 9, 2010
KIT 11.5FX19.5 CE MAHURKAR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code MSD·December 20, 2012
PKG, 5MM INSERT, RETENTION GRASPER, 33CM, P/N 0250080697 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