13 results
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32ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Latera Absorbable Nasal Implant
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
Arthroscope
FDA UDI
SOPRO-COMEG GmbH·04059082032696·
Arthroscope
FDA UDI
SOPRO-COMEG GmbH·04059082002743·
NAVIAID ICVI DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
FINGER AND EAR SENSORS AND NEONATAL-ADULT AND ADULT/PEDIATRIC ADHESIVE SENSORS FOR USE WITH NELLCOR R-CAL SPO2
FDA 510(k)
FDA Class 2
·Cardiovascular
T:SLIM X2 INSULIN PUMP WITH INTEROPERABLE TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·November 1, 2024
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·April 24, 2023
VERTEX RECONSTRUCTION SYSTEM
FDA Adverse Event
Injury
·WARSAW ORTHOPEDIC, INC.·Product code KWP·August 30, 2013
OT ULTRA METER
FDA Adverse Event
Injury
·LIFESCAN, INC.·Product code NBW·May 19, 2006
POLYFLEX
FDA Adverse Event
Injury
·GUIDANT ANGLETON/ST. PAUL·Product code NVN·July 13, 2011
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013
LIFECARE PCA 3
FDA Adverse Event
Injury
·HOSPIRA, INC.·Product code MEA·September 15, 2008
TRUE METRIX AIR
FDA Adverse Event
Malfunction
·TRIVIDIA HEALTH INC·Product code NBW·November 12, 2025