28 results
·
31ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
PRECISION XTRA PLUS OR OPTIUM PLUS, BLOOD GLUCOSE TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
N/A
FDA UDI
GEORGE TIEMANN & CO.·B58210512130·
Tiche PTA Balloon Dilatation Catheter
FDA UDI
BrosMed Medical Co.,Ltd.·06958481477276·
MODIFICATION TO SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CONCHATHERM 2000 HUMIDIFICATION SYSTEM, MODELS 500-00, -10, -20, -30, -40, -50, & -60
FDA 510(k)
FDA Class 2
·Anesthesiology
M-LNCS DC-I
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·November 21, 2016
DAILIES FRESHLOOK ILLUMINATE
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·March 9, 2012
M-LNCS DC-I
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·November 21, 2016
SYNCHRON LX 20 PRO CLINICAL SYSTEMS
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 8, 2011
SPINEMED TABLE - FDA 510(K) K051013
FDA Adverse Event
Other
·CERT HEALTH SCIENCES, LLC·Product code ITH·July 16, 2007
DAILIES FRESHLOOK ILLUMINATE
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·August 16, 2017
DAILIES FRESHLOOK ILLUMINATE
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·August 9, 2012
LNCS DC-I
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·March 11, 2017
RD SET DCI
FDA Adverse Event
Malfunction
·MASIMO - 40 PARKER·Product code DQA·February 17, 2017
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO OPERATIONS CO., VILLALBA·Product code DTB·April 10, 2013
SARNS CENTRIFUGAL PUMP
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEMS CORP.·Product code KFM·May 23, 2008
PRECISE PRO RX CAROTID STENT SYSTEM
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIM·April 12, 2011
DAILIES FRESHLOOK ILLUMINATE
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·August 8, 2014
DAILIES FRESHLOOK ILLUMINATE
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code LPL·August 8, 2014
DAILTES FRESHLOOK ILLUMINATE
FDA Adverse Event
Injury
·CIBA VISION GMBH·Product code MVN·December 6, 2012