8 results
·
36ms
·
Sources: EU EUDAMED, US FDA
TISSUE CULTURE FLASK PL 732 PLASTIC
FDA 510(k)
FDA Class 1
·Hematology
REFLECTION 3 ACETABULAR SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CYCLODIALYSIS SPAT. 15MM BLADE TITANIUM
FDA 510(k)
FDA Class 1
·Ophthalmic
ZIMMER AIR DERMATOME
FDA Adverse Event
Malfunction
·ZIMMER SURGICAL, INC.·Product code GFD·July 20, 2023
PROTECTA XT CRT-D
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014
SELOX SR 53
FDA Adverse Event
Malfunction
·BIOTRONIK SE & CO. KG·Product code DXY·October 1, 2010
GOBED+
FDA Adverse Event
Malfunction
·STRYKER MEDICAL·Product code FNL·November 2, 2012
OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.
FDA Enforcement
Class I
·Terminated·GE OEC Medical Systems, Inc·August 1, 2012