13 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RNA1C CONTROL FOR NYCOCARD HBA1C
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Mini-Dalbo®
FDA UDI
Cendres+Métaux SA·07640166513872·Mini-Dalbo®
Male part O
VOYAGER NC CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code MAF·December 4, 2008
X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
FDA 510(k)
FDA Class 1
·General Hospital
AARON 900 HIGH FREQUENCY DESSICCATOR/HANDPIECE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Death
·ABBOTT VASCULAR-CARDIAC THERAPIES·Product code NIQ·November 19, 2009
FATHOM GUIDEWIRE
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - FREMONT·Product code DQX·June 16, 2011
CONSERVE(R) PLUS CUP
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code KWA·April 10, 2013
PROXIMATE ILS CURVED CIR STAPL
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·April 12, 2011
RIATA ST ACTIVE FIXATION LEAD
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code LWS·May 27, 2008
FATHOM GUIDEWIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - SALT LAKE CITY·Product code DQX·February 23, 2010
FATHOM GUIDEWIRE
FDA Adverse Event
Injury
·SALT LAKE CITY·Product code DQX·February 23, 2010
Belmont Rapid Infuser, a Fluid Management System, Model FMS2000.
FDA Enforcement
Class II
·Terminated·Belmont Instrument Corporation·October 24, 2012