8 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
HbA1c Advanced
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ENDOSSEOUS DENTAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
MENTOR MEMORYGEL BREAST IMPLANT
FDA Adverse Event
Injury
·MENTOR TEXAS·Product code FTR·June 10, 2024
S-ROM M HEAD 36MM +9
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC US·Product code JDI·February 28, 2013
STOCKERT HEATER-COOLER SYS 3T
FDA Adverse Event
Other
·SORIN GROUP DEUTSCHLAND·Product code DWC·July 25, 2014
IQ GUIDE WIRE
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - COSTA RICA·Product code DQX·February 9, 2011
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP25; b) NEONATAL TRACHEOSTOMY TUBE 3.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP30; c) NEONATAL TRACHEOSTOMY TUBE 3.5FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP35; d) NEONATAL TRACHEOSTOMY TUBE 4.0FLEXTEND PLUS , Product Code/List Number/Item Code 60NFP40
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD Inc.·September 4, 2024