8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
DORC CORNEAL PUNCH BLOCK
FDA 510(k)
FDA Class 1
·Ophthalmic
MASTERGRAFT STRIP; MASTERGRAFT ULTRAMATRIX
FDA 510(k)
FDA Class 2
·Orthopedic
ON-LINE POWDER-FREE NITRILE EXAMINATION GLOVE, VIOLET COLORED
FDA 510(k)
FDA Class 1
·General Hospital
SURESCAN
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·May 23, 2014
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·November 13, 2012
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·September 10, 2010
VEPTR Vertical Expandable Prosthetic Titanium Rib, inferior cradles also known as caudal rib supports. The VEPTR/VEPTR II devices mechanically stabilize and/or correct thoracic deformities to allow the chest and lungs to grow.
FDA Enforcement
Class II
·Terminated·Synthes (USA) Products LLC·September 9, 2015
Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.
FDA Enforcement
Class II
·Terminated·STERILMED, INC.·December 16, 2015