9 results
·
28ms
·
Sources: EU EUDAMED, US FDA
DR. DEDO'S FAMILY EAR EXAMINATION KIT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
TRU® Waxing Screw RP Long .050" Hex
FDA UDI
STERNGOLD DENTAL LLC·00841549117428·Cylindrical stainless steel pins threaded at on...
STAGE III
FDA 510(k)
FDA Class 2
·Physical Medicine
TITANIUM GREENFIELD(R) VENA CAVA FILTER W/HOOKS
FDA 510(k)
FDA Class 2
·Cardiovascular
FUSION OMNI-TOME
FDA Adverse Event
Malfunction
·WILSON-COOK MEDICAL INC.·Product code KNS·May 23, 2014
PRIMO2X OXYGENATOR/SYSTEM
FDA Adverse Event
Other
·SORIN GROUP ITALIA·Product code DTZ·January 4, 2013
ARCHITECT C8000 SYSTEM
FDA Adverse Event
Malfunction
·ABBOTT MANUFACTURING, INC.·Product code CGZ·November 22, 2010
STAINLESS STEEL GREENFIELD VENA CAVA FILTER WITH 12F/4.0MM INTRODUCER SYSTEM
FDA Adverse Event
Death
·BOSTON SCIENTIFIC - CORK·Product code DTK·May 14, 2013
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N030; b) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N035; c) NEONATAL TRACH TUBE , Product Code/List Number/Item Code 60N040;
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024