8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
MEDCARE FORCEPS (THUMB, TISSUE)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Shoreline™ ACS
FDA UDI
Seaspine Orthopedics Corporation·10889981177140·Modular Trial, 16 x 14 x 5mm, 7 Deg Lordosis
EnCor MRI Introducer Set, EnCor Probe Introducer
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
STA - STACLOT DRVV SCREEN; STA - STACLOT DRVV CONFIRM
FDA 510(k)
FDA Class 1
·Hematology
ATTAIN ABILITY
FDA Adverse Event
Injury
·MPRI·Product code OJX·June 10, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010
4.0MM AGGRESSIVE PLUS CUTTER, FORMULA (5BX)
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY PUERTO RICO·Product code HRX·November 7, 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