12 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Contour+ (MVision AI Segmentation)
FDA 510(k)
FDA Class 2
·Radiology
UNIVERSAL SEGMENTED CYLINDER APPLICATOR SET AND UNIVERSAL STUMP APPLICATOR SET
FDA 510(k)
FDA Class 2
·Radiology
IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING
FDA 510(k)
FDA Class 2
·General Hospital
T:SLIM X2 INSULIN PUMP WITH BASAL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code OZO·March 18, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·August 29, 2025
CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Death
·EDWARDS LIFESCIENCES·Product code LWR·November 21, 2008
ASR UNI FEMORAL IMPL SIZE 45
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·September 9, 2011
GYNECARE MORCELLEX TISSUE MORCELLATOR
FDA Adverse Event
Malfunction
·ETHICON INC.·Product code HET·July 22, 2013
28MM M2A MOD HEAD -6MM NK
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDL·April 26, 2017
M2A-T M/H RAD SLD/APX SHL 50MM
FDA Adverse Event
Injury
·ZIMMER BIOMET, INC.·Product code KWA·September 24, 2017
M2A TAPER 37/28MM LINER
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code JDL·April 26, 2017
XP-XP Tibial Tray - Interlok 79 mm Item # 195758
FDA Enforcement
Class II
·Terminated·Zimmer Biomet, Inc.·September 18, 2019