22 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Merit Medical®
FDA UDI
Merit Medical Systems, Inc.·00884450179185·
NON-INVASIVE VENTILATION NIV OPTION, MODEL 84 14 474
FDA 510(k)
FDA Class 2
·Anesthesiology
MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM
FDA 510(k)
FDA Class 2
·Cardiovascular
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·December 23, 2011
WAVEWRITER ALPHA PRIME 16
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·October 1, 2024
CELOX GAUZE
FDA Adverse Event
Injury
·MEDTRADE PRODUCTS LIMITED·Product code FRO·February 14, 2023
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTL.·Product code MNI·September 16, 2011
CELOX GAUZE
FDA Adverse Event
Injury
·MEDTRADE PRODUCTS LIMITED·Product code FRO·October 12, 2022
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTL.·Product code MNI·October 14, 2011
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·November 11, 2011
PASS LP
FDA Adverse Event
Injury
·MEDICREA INTERNATIONAL·Product code MNI·April 5, 2012
COAGUCHEK ® XS SYSTEM
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code GJS·April 26, 2013
FIRST PICC KIT W/INTROSTYLE INTRODUCER
FDA Adverse Event
Malfunction
·ARGON MEDICAL DEVICES, INC.·Product code FOZ·April 6, 2011
LIFEPAK 12 DEFIBRILLATOR MONITOR SERIES
FDA Adverse Event
Malfunction
·PHYSIO-CONTROL, INC.·Product code MKJ·July 17, 2008
PASS LP
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA TECHNOLOGIES·Product code MNI·April 17, 2013
PASS LP
FDA Adverse Event
Injury
·MEDICREA·Product code MNI·April 17, 2013
CELOX GAUZE
FDA Adverse Event
Injury
·MEDTRADE PRODUCTS LIMITED·Product code QSY·June 10, 2025
Instructions For Use document of the GPS Trackers.
FDA Enforcement
Class II
·Terminated·Blue Ortho·November 4, 2020