8 results
·
25ms
·
Sources: EU EUDAMED, US FDA
SKIN STAPLE REMOVER KIT
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Damon 3
FDA UDI
ORMCO CORPORATION·00889989052732·L3R DAMON 3 .022 0/+5/0 HK
IDEIA(TM) CHLAMYDIA, MODIFICATION
FDA 510(k)
FDA Class 2
·Microbiology
HEMOCARD-AS
FDA 510(k)
FDA Class 2
·Hematology
2008K2 HEMODIALYSIS MACHINE
FDA Adverse Event
Malfunction
·CONCORD MANUFACTURING·Product code KDI·June 5, 2014
ODYSSEY
FDA Adverse Event
Malfunction
·PERMEDICS, INC.·Product code MUJ·November 4, 2010
840 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN, FORMERLY NELLCOR PURITAN·Product code CBK·January 9, 2013
PKG, SPRING HANDLE, P/N 0250080237. 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