22 results · 22ms · Sources: EU EUDAMED, 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