7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
FreedomFlow Orbital Circumferential Atherectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
Trinity Plus Wrinkle Reducer
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003
FDA 510(k)
FDA Class 2
·Orthopedic
CURRENT ACCEL VR, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·September 11, 2011
PINNACLE PELVIC FLOOR REPAIR KIT
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code FTM·November 21, 2008
TRILOGY SHELL WITHOUT HOLES
FDA Adverse Event
Injury
·ZIMMER, INC.·Product code MEH·July 19, 2013
PKG, 5MM X 45CM INSERT, ALLIS FORCEPS, DOUBLE ROW TEETH, P/N 0250080754 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