8 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PULPDENT EDTA PREPARATIONS
FDA 510(k)
FDA Class 2
·Dental
Nu-Edge Cobalt Chromium Brackets
FDA UDI
TP ORTHODONTICS INC·00192029046944·LR 2nd BI W/DISTAL HK
Access Intact PTH
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GLYCOHEMOSURE HBA1C CONTROL
FDA 510(k)
FDA Class 2
·Hematology
SECURE II MED/SURG BED
FDA Adverse Event
Malfunction
·STRYKER CORP., MEDICAL DIV.·Product code FNL·November 30, 2010
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·January 29, 2013
SMARTSET MV 40G - EO
FDA Adverse Event
Injury
·DEPUY CMW 9610921·Product code LOD·July 14, 2014
Exactech Equinoxe Humeral Liner: Item Numbers: a) 320-40-00, b) 320-40-03; Shoulder Arthroplasty
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·April 10, 2024