14 results
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30ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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IMAGER II ANGIOGRAPHIC CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
DreamStation
FDA UDI
Respironics, Inc.·00606959040465·DreamStation Nonin SpO2 Cable
OsteoMed
FDA UDI
OSTEOMED LLC·00845694055659·1.2mm Orbital Floor Plate, Preformed, Right, .5...
HANDHELD PULSE OXIMETER MODEL M800
FDA 510(k)
FDA Class 2
·Cardiovascular
CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100
FDA 510(k)
FDA Class 2
·Cardiovascular
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·March 30, 2026
BD SAFETYGLIDE¿ NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·February 4, 2019
BD SAFETYGLIDE¿ SHIELDING STERILE IM HYPODERMIC NEEDLE
FDA Adverse Event
Malfunction
·BECTON DICKINSON MEDICAL SYSTEMS·Product code FMI·June 25, 2018
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DTB·January 13, 2014
WALLFLEX? COLONIC
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - GALWAY·Product code MQR·May 21, 2013
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·June 13, 2011
SYNCARDIA 70CC TEMPORARY TOTAL ARTIFICIAL HEART (TAH-T)
FDA Adverse Event
Injury
·Product code LOZ·May 3, 2021
THINFLAP SYSTEM CROSS-DRIVE, SELF-DRILLING SCREW 1.5X4MM
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code GWO·April 16, 2018
Exactech Equinoxe GLENOID,KEELED, CEMENTED,47, 50, 53 head, beta curvature, Sizes: a) Small, Item Number 314-02-12, b) Medium, Item Number 314-02-13, c) Large, Item Number 314-02-14, d) Extra Large, Item Number 314-02-15, Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024