11 results
·
21ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Paragon 8F Balloon Guide Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
MARS HOLTER ANALYSIS WORKSTATION
FDA 510(k)
FDA Class 2
·Cardiovascular
CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 21, 2025
GLOBAL ADVANTAGE HUM HD 44X15
FDA Adverse Event
Injury
·JOHNSON & JOHNSON MEDICAL (SUZHOU) LTD. 3006356043·Product code KWT·November 6, 2014
ASR UNI FEMORAL IMPL SIZE 49
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 2, 2011
VALIANT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·July 18, 2013
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 9, 2026
BD VERITOR¿ SYSTEM FOR RAPID DETECTION OF FLU A+B CLIA-WAIVED KIT
FDA Adverse Event
Malfunction
·BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.·Product code PSZ·February 10, 2026
BD VERITOR¿ PLUS ANALYZER
FDA Adverse Event
Malfunction
·BECTON DICKINSON & CO. (SPARKS)·Product code PSZ·March 7, 2025
GSOURCE, LLC
FDA Adverse Event
Malfunction
·GSOURCE, LLC·Product code HTW·January 7, 2025