7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
CENTRICON MICRO-CONCENTRATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS
FDA 510(k)
FDA Class 2
·Ophthalmic
CONSENSUS VITALITE TIBIAL INSERT
FDA 510(k)
FDA Class 2
·Orthopedic
COULTER LH 500 HEMATOLOGY ANALYZER
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code GKZ·May 27, 2014
BRAVO
FDA Adverse Event
Malfunction
·GIVEN IMAGING LTD.·Product code FFT·November 7, 2012
ACRYSOF IQ TORIC
FDA Adverse Event
Other
·ALCON RESEARCH, LTD/ HUNTINGTON·Product code HQL·September 9, 2010
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