14 results · 30ms · Sources: EU EUDAMED, 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