27 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SMARTHEART
FDA 510(k)
FDA Class 2
·Cardiovascular
N/A
FDA UDI
HANS RUDOLPH, INC.·00874750003143·75 V2 PETITE 22ID ELBOW W/HG
Plateau Spacer System
FDA UDI
Life Spine, Inc.·00190837045210·Straight Sizer, 11mm
Proximity
FDA UDI
ALPHATEC SPINE, INC.·00190376694467·PROXIMITY VA SELF-TAP SCREW, 3.5 x 14mm
Complete Cervical
FDA UDI
Seaspine Orthopedics Corporation·10889981040604·Screw - Self-Tapping - 3.5x14mm
Segmental Plating System
FDA UDI
ALPHATEC SPINE, INC.·00190376545394·SPS VA Self-Tap Screw, 3.5 x 14 mm
Vu a-POD™
FDA UDI
Seaspine Orthopedics Corporation·10889981037819·35x27 14mm Spin Plate. The Vu a-POD interverteb...
PRO-V COAT
FDA 510(k)
FDA Class 2
·Dental
PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL
FDA 510(k)
FDA Class 2
·Radiology
N/A
FDA UDI
SALTER LABS·00607411400902·Adult. EtCO2 Divided Nasal Cannula with CO2 m...
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code MQR·April 12, 2018
PRONOVA BLUE MONO POLY(HEXAFLUOROPROPYLENE)SUTURE
FDA Adverse Event
Malfunction
·ETHICON, INC.·Product code GAW·May 15, 2013
GRANUFLO
FDA Adverse Event
Death
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KPO·September 11, 2014
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·June 1, 2011
TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code JEY·May 31, 2019
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code MQR·August 17, 2017
EVOLUTION BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code FAD·March 12, 2015
WALTER LORENZ TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code LZD·August 29, 2017
EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
FDA Adverse Event
Malfunction
·COOK IRELAND LTD·Product code MQR·March 15, 2018
EVOLUTION ESOPHAGEAL CONTROLLED-RELEASE STENT - FULLY COVERED
FDA Adverse Event
Injury
·COOK IRELAND LTD·Product code ESW·November 12, 2014