30 results
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23ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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SDS2.2 dental implant
FDA 510(k)
FDA Class 2
·Dental
MEDI
FDA UDI
MEDI MANUFACTURING, INC.·04051526768505·GENUMEDI PSS GREEN VI
Oticon
FDA UDI
Oticon A/S·05707131338808·SIYA 2, BTE 13 2.4G 85 C090
Hayden Medical
FDA UDI
Hayden Medical, Inc.·00840319741436·Hartman Nasal Cutting Forceps, 5" (12.5cm), 11m...
EP15 SOFTWARE MODULE, EP25 SOFTWARE MODULE
FDA 510(k)
FDA Class 2
·Ear, Nose, Throat
FORA V20 BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·June 16, 2025
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·June 16, 2025
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·October 22, 2025
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·February 12, 2025
PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP
FDA Adverse Event
Injury
·MEDTRONIC MINIMED·Product code MDS·July 28, 2011
SYNCHROMED II
FDA Adverse Event
Injury
·MDT PUERTO RICO OPERATIONS CO·Product code LKK·June 26, 2013
ACCUMAXTM SINGLE USE HOLMIUM LASER FIBER
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code GEX·October 21, 2014
CARDIOCHEK PLUS ANALYZERQ
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·August 18, 2022
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·July 28, 2023
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·May 24, 2024
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·January 6, 2023
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·January 11, 2024
CARDIOCHEK PLUS ANALYZER
FDA Adverse Event
Malfunction
·PTS DIAGNOSTICS·Product code CGA·November 21, 2023
KING LAD SILI CONE SINGLE USE, King Systems, 10 devices/case, ETO Sterile Size 5 / Adult Silicone King LAD¿ Patient Size: >70kg Product Usage: Laryngeal airway
FDA Enforcement
Class II
·Terminated·King Systems Corp.·November 28, 2012