8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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RADIAS FOLATE ENZYME IMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Nu-Edge Cobalt Chromium Brackets
FDA UDI
TP ORTHODONTICS INC·00192029047200·LR CUS NO HK Torque -7, Tip +3 0.46mm (0.018")
STERILE DRAINAGE SYSTEM
FDA 510(k)
FDA Class 1
·Gastroenterology, Urology
GCI Surgical Gown
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LCS COMP RP INSERT LG 10MM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS, INC.·Product code NJL·December 17, 2010
ADVANIX¿ BILIARY
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FGE·January 29, 2013
STRYKEFLOW2 WITH DISPOSABLE TIP (6BX)
FDA Adverse Event
Malfunction
·STRYKER ENDOSCOPY-SAN JOSE·Product code LJH·July 15, 2014
Portex Endotracheal Tube, Item Codes 100/105/025 100/105/030 100/105/035 100/111/020 100/111/025 100/111/030 100/111/035 100/111/035 100/126/025 100/126/030 100/126/035 100/127/025 100/127/030 100/127/035 100/141/025 100/141/030 100/141/035
FDA Enforcement
Class I
·Ongoing·Smiths Medical ASD, Inc.·March 19, 2025