7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
COUNT-A-PART PLUS
FDA 510(k)
FDA Class 2
·Hematology
RMU-1000 AUTOMATED CHEST COMPRESSION SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PERMANENT PACING LEAD, MODEL PY2
FDA 510(k)
FDA Class 3
·Cardiovascular
ALYTE Y-MESH GRAFT, STERILE
FDA Adverse Event
Injury
·C.R. BARD, INC. (COVINGTON) -1018233·Product code OTO·May 30, 2014
4.0MM TI MATRIX POLYAXIAL SCREW 20MM THREAD LENGTH
FDA Adverse Event
Injury
·SYNTHES BRANDYWINE·Product code NKB·November 21, 2012
CARPENTIER-EDWARDS PERIMOUNT RSR PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·September 22, 2010
PKG, 5MM INSERT, BIOPSY FORCEPS, PUNCH, 45CM, P/N 0250080580 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