9 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Left, VERASENSE for Zimmer Biomet Persona CR C-D/3-9 Right, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Left, VERASENSE for Zimmer Biomet Persona CR E-F/3-11 Right, VERASENSE for Zimmer Biomet Persona CR G-H/7-12 Left
FDA 510(k)
FDA Class 2
·Neurology
Reveal
FDA UDI
Oticon A/S·05707131343567·G10, MINIRITE T 312 2.4G C093 REVEAL
ARTIS ONE
FDA 510(k)
FDA Class 2
·Radiology
GRANDIO SO FLOW
FDA 510(k)
FDA Class 2
·Dental
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 23, 2025
TENDRIL ST
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, CRMD·Product code NVN·January 13, 2014
GEMSTAR PM THERAPY S
FDA Adverse Event
Malfunction
·HOSPIRA INC.·Product code FRN·July 14, 2011
M2A-MAGNUM PF CUP 60ODX54ID
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code KWA·June 27, 2013
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
FDA Enforcement
Class II
·Ongoing·Megadyne Medical Products, Inc.·August 9, 2023