12 results
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22ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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Multix Fusion Max
FDA 510(k)
FDA Class 2
·Radiology
BI-METRIC HIP SYSTEM
FDA UDI
Biomet Orthopedics, LLC·00880304254770·
BREATH ALCOHOL CHECK .02 AND BREATHSCAN .02 DETECTION SYSTEMS
FDA 510(k)
FDA Class 1
·Clinical Toxicology
FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·June 25, 2025
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
UNKNOWN PLATE
FDA Adverse Event
Malfunction
·BIOMET MICROFIXATION·Product code HRS·April 21, 2026
IMPAX CV REPORTING
FDA Adverse Event
Malfunction
·AGFA HEALTHCARE CORP.·Product code LLZ·June 11, 2013
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·July 15, 2011
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·October 10, 2014
EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
FDA Adverse Event
Death
·COOK IRELAND LTD·Product code ESW·December 31, 2019