8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
ROTACHROM HEPARIN TEST KIT
FDA 510(k)
FDA Class 2
·Hematology
Novo Surgical
FDA UDI
NOVO SURGICAL, INC.·G5869435150·arthroscopic iron punch, working length 3 5/8" ...
Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants
FDA 510(k)
FDA Class 2
·Dental
GRAFTSAVER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
ACRYSOF
FDA Adverse Event
Other
·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·December 2, 2010
TOTALCARE BED
FDA Adverse Event
Malfunction
·HILL-ROM, INC.·Product code FNL·January 9, 2013
COBAS 6000 E601 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·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