8 results
·
36ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Infrared Forehead Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
INERTIA PEDICLE SCREW SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
XYLOS VESSEL GUARD
FDA 510(k)
FDA Class 2
·Cardiovascular
MCLEAN-RING NASOJEJUNAL FEEDING TUBE SET
FDA Adverse Event
Injury
·COOK INC·Product code KNT·November 10, 2021
ULTRACISION HARMONIC SCALPEL CURVED SHEARS (LCS) PISTOL GRIP 36CM - 15MM ACTIVE
FDA Adverse Event
Malfunction
·ETHICON ENDO SURGERY, INC. (CINCINNATI)·Product code GEI·October 9, 2008
GRAFTON DBM PUTTY
FDA Adverse Event
Injury
·OSTEOTECH, INC.·Product code NUN·July 29, 2011
PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - GALWAY·Product code NIQ·June 26, 2013
Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·April 27, 2016