27 results · 23ms · Sources: EU EUDAMED, US FDA

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FDA 510(k)
FDA Class 2 ·Radiology

QUADROX-I NEONATAL MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE/BIOLINE COATING

FDA 510(k)
FDA Class 2 ·Cardiovascular

PROSTIVA RF THERAPY HAND PIECE, MODEL 8929

FDA 510(k)
FDA Class 2 ·Gastroenterology, Urology

VKMO 11000 #QUADROX-I NEO. MIT RESERVOIR

FDA Adverse Event
Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·March 27, 2015

ROSA RECON PLATFORM 220V

FDA Adverse Event
Injury ·ZIMMER CAS·Product code OLO·February 1, 2022

ROSA RECON PLATFORM 220V

FDA Adverse Event
Injury ·ZIMMER CAS·Product code OLO·February 4, 2022

ROSA RECON PLATFORM 220V

FDA Adverse Event
Injury ·ZIMMER CAS·Product code OLO·February 1, 2022

ROSA RECON PLATFORM 220V

FDA Adverse Event
Injury ·ZIMMER CAS·Product code OLO·April 4, 2022

ROSA RECON PLATFORM 220V

FDA Adverse Event
Injury ·ZIMMER CAS·Product code OLO·March 9, 2022

ROSA RECON PLATFORM 220V

FDA Adverse Event
Malfunction ·ZIMMER CAS·Product code OLO·March 21, 2022

DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code QBJ·July 14, 2025

QUADROX-I NEO. MIT RESERVOIR

FDA Adverse Event
Malfunction ·MAQUET CARDIOPULMONARY AG·Product code DTN·April 16, 2015

OXYGENATOR, CARDIOPULMONARY BYPASS

FDA Adverse Event
Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015

OXYGENRATOR, CARDIOPULMONARY BYPASS

FDA Adverse Event
Injury ·MAQUET CARDIOPULMONARY AG·Product code DTZ·April 27, 2015

HEARTSTART MRX - EMS DEFIBRILLATOR

FDA Adverse Event
Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·June 11, 2013

PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code MDS·July 18, 2011

HARMONIC FOCUS SCALPEL

FDA Adverse Event
Malfunction ·ETHICON ENDO-SURGERY, INC.·Product code LFL·September 19, 2008

ROSA RECON PLATFORM 220V

FDA Adverse Event
Malfunction ·ZIMMER BIOMET, INC.·Product code OLO·November 8, 2021

ROSA KNEE PLATFORM GB PL G

FDA Adverse Event
Injury ·ZIMMER CAS·Product code OLO·January 13, 2022

ROSA RECON PLATFORM 220V

FDA Adverse Event
Injury ·ZIMMER CAS·Product code OLO·January 10, 2022