10 results
·
19ms
·
Sources: EU EUDAMED, US FDA
CHECK-UP PLAQUE FIGHTING GUM
FDA 510(k)
FDA Class 1
·Dental
PALEY TRANSPARENT MANIFOLD
FDA 510(k)
FDA Class 2
·Cardiovascular
MODIFICATION TO HEALTH BUDDY APPLIANCE
FDA 510(k)
FDA Class 2
·Cardiovascular
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code NIQ·June 10, 2014
SURGICEL ABSORBABLE HEMOSTAT
FDA Adverse Event
Injury
·ETHICON, INC.·Product code LMG·December 6, 2012
PD CYCLER 110 VOLT HOME CHOICEPRO AUTOMATED
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - LARGO·Product code FKX·October 7, 2010
LOGIC FEMORAL PS CEM LEFT SZ 5
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 23, 2024
THREE PEG PATELLA 38MM
FDA Adverse Event
Injury
·EXACTECH, INC.·Product code JWH·August 22, 2024
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
DATEX-OHMEDA S/5 SINGLE-WIDTH AIRWAY MODULE, E-MINIC AND ACCESSORIES. DATEX-OHMEDA S/5TM FM WITH L-FICU04 ANDL-FICUO4A SOFTWARE AND N-FCREC MODULE **(OUS only). E-miniC and accessories is indicated for monitoring C02 and respiration rate of all hospital patients.
FDA Enforcement
Class I
·Terminated·GE Healthcare, LLC·July 30, 2014