16 results · 22ms · Sources: EU EUDAMED, US FDA

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WOMED NICRO-CRAFT POWER SYSTEM

FDA 510(k)
FDA Class 2 ·Ear, Nose, Throat

Novalung System

FDA 510(k)
FDA Class 2 ·Cardiovascular

LUNG VOLUME & PRESSURE MONITOR

FDA 510(k)
FDA Class 2 ·Anesthesiology

BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code JCF·June 6, 2018

BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code JCF·June 7, 2018

BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code JCF·June 6, 2018

BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code JCF·April 27, 2018

BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code JCF·April 16, 2018

G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

FDA Adverse Event
Malfunction ·DEXCOM, INC.·Product code MDS·May 5, 2014

SPRINT FIDELIS

FDA Adverse Event
Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012

CONCERTO CRT-D DR

FDA Adverse Event
Injury ·MEDTRONIC MED REL, INC.·Product code NIK·August 10, 2010

BD VACUTAINER® CPT¿ NH: ~130 IU FICOLL¿: 2.0ML

FDA Adverse Event
Malfunction ·BECTON, DICKINSON & CO.·Product code JCF·June 5, 2018

PALL ULTIPOR 25 BREATHING SYSTEM FILTER

FDA Adverse Event
Injury ·PALL NEWQUAY·Product code CAH·July 13, 2018

PALL ULTIPOR 100 BREATHING SYSTEM FILTER

FDA Adverse Event
Injury ·PALL NEWQUAY·Product code CAH·April 18, 2017

PROTECT SLEEVE 13 F/RETROGR-APPROACH

FDA Adverse Event
Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code FZX·June 29, 2018

ACCOLADE SR SL MRI (Model L310)

FDA Enforcement
Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025