22 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Clarus Peel-Away Introducer Sheath
FDA 510(k)
FDA Class 2
·Neurology
TREPSAT FACE-LIFT SCISSORS
FDA UDI
SONTEC INSTRUMENTS, INC.·00192896055995·TREPSAT FACE-LIFT SCISSORS STRAIGHT BLADES POWE...
ASCENSION ANKLE FUSION NAIL SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
CARBODISSECTING ENDOSCOPE
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 12, 2024
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·May 20, 2010
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·May 20, 2010
ACRYSOF RESTOR
FDA Adverse Event
Injury
·ALCON RESEARCH, LTD./HUNTINGTON·Product code MFK·May 20, 2010
INRATIO
FDA Adverse Event
Malfunction
·BIOSITE INCORPORATED·Product code JPA·July 31, 2009
COLLEAGUE CX VOLUMETRIC INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·October 20, 2008
HEART START XL
FDA Adverse Event
Malfunction
·AGILENT TECHNOLOGIES, INC.·Product code MKJ·June 30, 2011
UNK
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 2, 2013
PECTUS BAR
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·April 30, 2010
TAXUS EXPRESS2
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC·Product code NIQ·December 5, 2006
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·November 20, 2025
UNK - SCREWS
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HWC·March 3, 2021
UNK - PLATES: SPINE
FDA Adverse Event
Injury
·SYNTHES GMBH·Product code HRS·March 3, 2021
SCENARIA View: Software Version V1.08, V1.09B, V1.09C, V1.09D, V1.0B, V1.0C
FDA Enforcement
Class II
·Ongoing·FUJIFILM Healthcare Americas Corporation·September 21, 2022
Toshiba Infinix-i X-Ray System. A radiographic and fluoroscopic x-ray system for use in diagnostic and angiographic procedures.
FDA Enforcement
Class II
·Terminated·Toshiba American Medical Systems Inc·April 3, 2013
EMBLEM MRI S-ICD Model A219
FDA Enforcement
Class I
·Terminated·Boston Scientific Corporation·February 17, 2021