7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
TRIGLYCERIDES REAGENT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECTROSURGICAL PENCILS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KEGEL SMART, KEGELSMART PEARL
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HOMECHOICE PRO
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·May 30, 2014
SIGNATURE KNEE GUIDES 03-05
FDA Adverse Event
Malfunction
·BIOMET ORTHOPEDICS·Product code JWH·November 20, 2012
SYNCHROMED II
FDA Adverse Event
Malfunction
·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LKK·September 17, 2010
PKG, NEEDLE NOSE FORCEPS, P/N 0250080288. 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