12 results
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29ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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uMI 550 PET/CT System
FDA 510(k)
FDA Class 2
·Radiology
MUSTMINI OCCIPITAL SCREW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025
PVS MODEL 1.0
FDA 510(k)
FDA Class 2
·Radiology
PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST
FDA 510(k)
FDA Class 2
·Anesthesiology
QUICKSITE LV
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, INC. CRMD·Product code OJX·January 13, 2014
TRAPEZOID? RX
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code LQC·June 21, 2013
MERIT CUSTOM KIT
FDA Adverse Event
Malfunction
·MERIT MEDICAL SYSTEMS, INC.·Product code DQO·July 12, 2011
URETERAL BRUSH BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FDX·November 15, 2023
MUSTMINI OCCIPITAL SCREW
FDA Adverse Event
Injury
·MEDACTA INTERNATIONAL SA·Product code NKG·February 11, 2025
URETERAL BRUSH BIOPSY SET
FDA Adverse Event
Malfunction
·COOK INC·Product code FDX·January 7, 2022
MUST MINI OC PRE-BENT TRANSITION ROD 75° Ø3.5/4X 200MM (STE)
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL SA·Product code NKG·April 25, 2024
bvi Beaver Safety Sideport Knife: (a) 1.0mm, 45o, REF 378210 (b) 1.2mm, 45o, REF 378212 (c) 115mm, 45o, REF 378231 Product Usage: Specialty blades and knives are used for stab and cut incisions in ophthalmic, ENT and other surgical applications.
FDA Enforcement
Class II
·Terminated·Beaver-Visitec International Inc.·February 7, 2018