22 results
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23ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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TDP CQ-27 HEAT LAMP
FDA 510(k)
FDA Class 2
·Physical Medicine
GEN4 Direct Access
FDA UDI
CURBELL MEDICAL PRODUCTS, INC.·00840828105781·GEN4 Direct Access
NorthStar
FDA UDI
Seaspine Orthopedics Corporation·10889981196073·Poly. Screw, 3.5mm x 38mm
Cortium Universal OCT Spinal Fixation System
FDA UDI
Ulrich Medical Usa, Inc.·00814386026154·Smooth shank screw, Ø 3.5mm, length 38mm, high ...
AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A
FDA 510(k)
FDA Class 2
·Neurology
MALLORY/HEAD LATERALIZED PRESS-FIT FEMORAL
FDA 510(k)
FDA Class 2
·Orthopedic
AUTOSOFT XC
FDA Adverse Event
Malfunction
·Product code FPA·May 23, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·October 8, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·July 3, 2024
THERMOPHORE AUTOMATIC MOIST HEAT PACK
FDA Adverse Event
Malfunction
·BATTLE CREEK EQUIPMENT COMPANY·Product code IRT·February 11, 2013
PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - MAPLE GROVE·Product code NIQ·March 1, 2011
TAXUS EXPRESS2 PACLITAXEL-ELUTING CORONARY STENT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC CORPORATION·Product code NIQ·February 26, 2008
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 21, 2024
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·June 26, 2024
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·June 26, 2024
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·June 26, 2024
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·June 26, 2024
AUTOSOFT XC
FDA Adverse Event
Malfunction
·UNOMEDICAL A/S·Product code FPA·June 21, 2024
AUTOSOFT XC
FDA Adverse Event
Injury
·UNOMEDICAL A/S·Product code FPA·June 26, 2024
smiths medical portex Venn Reusable Tracheal Tube Introducer, 15Ch x 60cm, REF 14-504-17 and REF 14-504-17JP
FDA Enforcement
Class II
·Ongoing·Smiths Medical ASD, Inc.·December 4, 2024