11 results
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21ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Arthrex 3.5 mm Locking Compression Plates
FDA 510(k)
FDA Class 2
·Orthopedic
POLARCUP DUAL MOBILITY SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
G-1 VERSION 3, MODEL 10048
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
F180NR DIALYZER FILTER
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·November 5, 2008
COLLEAGUE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 24, 2011
AFX SYSTEM
FDA Adverse Event
Injury
·ENDOLOGIX, INC.·Product code MIH·July 12, 2013
ELECSYS TSH ASSAY
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JLW·July 27, 2018
FT3 III - FREE TRIIODOTHYRONINE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code CDP·July 27, 2018
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·August 20, 2024
GUNTHER TULIP VENA CAVA FILTER RETRIEVAL SET
FDA Adverse Event
Malfunction
·COOK INC·Product code MMX·November 18, 2024
Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024