54 results
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25ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Sterile Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (Blue)
FDA 510(k)
FDA Class 1
·General Hospital
7500 V MASK
FDA UDI
HANS RUDOLPH, INC.·00874750003976·SWVLPORT ELB 75 22OD PC GRN
ABSORBENT PAPER POINTS
FDA UDI
DiaDent Group International·08806383512169·"An absorbent paper points is an endodontic pap...
PREMIUM MICRO CANNULA SET
FDA UDI
The Wells Johnson Company·B458201531000·Cannula Set, Premium Micro Cannula Set, contain...
RPI REPLACEMENT PHOTOTHERAPY LIGHTS
FDA 510(k)
FDA Class 2
·General Hospital
iHealth Infrared No-Touch Forehead Thermometer
FDA 510(k)
FDA Class 2
·General Hospital
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 12, 2024
PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT
FDA Adverse Event
Injury
·ETHICON INC.·Product code NEW·April 4, 2018
CYPHER SIROLIMUS-ELUTING CORONARY STENT
FDA Adverse Event
Injury
·CORDIS DE MEXICO·Product code NIQ·October 17, 2008
EON MINI RECHARGEABLE IPG
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·August 4, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·July 2, 2013
FREESTYLE AORTIC ROOT BIOPROSTHESIS
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code LWR·January 13, 2017
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·June 8, 2021
ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM
FDA Adverse Event
Injury
·KINETIC CONCEPTS, INC.·Product code OMP·July 14, 2021
COREVALVE REVALVING SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·January 13, 2017
UNKNOWN VALVE/SHUNT
FDA Adverse Event
Injury
·MEDTRONIC NEUROSURGERY·Product code JXG·September 25, 2015
FOUNDATION KNEE
FDA Adverse Event
Injury
·ENCORE MEDICAL L.P.·Product code JWH·August 25, 2022
CARPENTIER-EDWARDS® PERIMOUNT® AORTIC PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·March 31, 2015
SYNVISC ONE (SYNVISC ONE)
FDA Adverse Event
Injury
·GENZYME BIOSURGERY (RIDGEFIELD)·Product code MOZ·November 26, 2015
ECHELON ENDOPATH STAPLER
FDA Adverse Event
Injury
·ETHICON ENDO-SURGERY, LLC.·Product code GDW·October 18, 2019