27 results
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25ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Aplio a550, Aplio a450, Aplio a, Diagnostic Ultrasound System, Software V5.1
FDA 510(k)
FDA Class 2
·Radiology
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113356·CLEAR CORNEA KNIFE 2.8MM (BX/5)
Ophthalmic Knife
FDA UDI
KATENA PRODUCTS, INC.·00841668113332·PHACO KNIFE 3.0MM ANGLED (BX/5)
Corneal Trephine
FDA UDI
KATENA PRODUCTS, INC.·00841668112984·CORNEAL TREPHINE BLADE9.5MM
NOBELACTIVE TIULTRA NP 3.5X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·May 31, 2021
NOBELACTIVE TIULTRA NP 3.5X13MM
FDA Adverse Event
Injury
·NOBEL BIOCARE AB·Product code DZE·May 31, 2021
NAVITRACK SYSTEM TOTAL HIP REPLACEMENT,MODEL 900.200
FDA 510(k)
FDA Class 2
·Neurology
PROTEMP H
FDA 510(k)
FDA Class 2
·Dental
PENTAX
FDA Adverse Event
Malfunction
·HOYA CORPORATION PENTAX TOKYO OFFICE·Product code FDT·January 10, 2024
MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code NKM·October 23, 2024
MITRACLIP® SYSTEM STEERABLE GUIDE CATHETER
FDA Adverse Event
Injury
·ABBOTT MEDICAL·Product code DRA·October 24, 2024
MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM
FDA Adverse Event
Death
·ABBOTT MEDICAL·Product code NKM·October 23, 2024
ACCU-CHEK ® AVIVA TEST STRIPS
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code LFR·October 13, 2010
EPI-SENSE ST COAGULATION DEVICE
FDA Adverse Event
Injury
·ATRICURE, INC.·Product code OCM·November 17, 2023
ORTHO PROVUE
FDA Adverse Event
Malfunction
·ORTHO CLINICAL·Product code KSZ·October 14, 2008
PARADIGM REAL-TIME INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·August 2, 2011
UKNOWN IMPLANTABLE INFUSION CATHETER
FDA Adverse Event
Injury
·MEDTRONIC NEUROMODULATION SULLIVAN LAKE·Product code LKK·July 2, 2013
MEDTRONIC LEAD
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code DXY·July 8, 2024
MEDTRONIC IPG
FDA Adverse Event
Death
·MEDTRONIC, INC.·Product code NVZ·July 8, 2024
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
FDA Adverse Event
Injury
·MEDTRONIC, INC.·Product code OAE·September 23, 2024