9 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
Geistlich Wound Matrix
FDA 510(k)
FDA Unclassified
·Unknown
ARCHITECT HBA1C, ARCHITECT HBA1C, AND ARCHITECT HBA1C
FDA 510(k)
FDA Class 2
·Hematology
ACIES
FDA 510(k)
FDA Class 2
·Radiology
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 3, 2025
OT VERIO IQ METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·October 15, 2014
LTV
FDA Adverse Event
Malfunction
·CAREFUSION 203, INC.·Product code CBK·May 23, 2013
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 22, 2011
GMK-SPHERE TIBIAL TRAY FIXED CEMENTED SIZE T3-I4 R
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code JWH·November 20, 2020
Ingenia 3.0T-a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781342 781377
FDA Enforcement
Class II
·Completed·Philips North America Llc·September 15, 2021