9 results
·
18ms
·
Sources: EU EUDAMED, US FDA
R1698,R1701,R1215,R1700 & R860 POWERED TABLES
FDA 510(k)
FDA Class 1
·Physical Medicine
2D Hip Planning Software
FDA 510(k)
FDA Class 2
·Radiology
PERI-LOC PERIARTICULAR LOCKED PLATING SYSTEM FOR THE UPPER EXTREMITY
FDA 510(k)
FDA Class 2
·Orthopedic
COBAS C 503 ANALYTICAL UNIT
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·January 8, 2026
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 13, 2014
SYNCHROMED EL
FDA Adverse Event
Injury
·RICE CREEK MFG·Product code LKK·December 7, 2012
SMALL POINTER
FDA Adverse Event
Malfunction
·STRYKER INSTRUMENTS-KALAMAZOO·Product code HAW·June 23, 2015
2.4MM UNIVERSAL DRILL GUIDE
FDA Adverse Event
Malfunction
·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·August 22, 2019
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