23 results
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28ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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PERIFLUX 6000
FDA 510(k)
FDA Class 2
·Anesthesiology
Orthos
FDA UDI
ORMCO CORPORATION·00889989053418·U6L SL B/T ORTHOS 22 FLG -10/0/10
Symmetry Deschamps
FDA UDI
ASPEN SURGICAL PRODUCTS, INC.·00887482054925·Symmetry® Ligature, Desch, Sharp Left, 8 in
ARTHREX DISTAL EXTREMITY PLATE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
RII INFRARED EAR THERMOMETER, MODEL: TH60N
FDA 510(k)
FDA Class 2
·General Hospital
980 VENTILATOR
FDA Adverse Event
Malfunction
·COVIDIEN·Product code CBK·December 14, 2016
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
FDA Adverse Event
Malfunction
·TANDEM DIABETES CARE·Product code QFG·June 24, 2022
PROPHECY INFINITY
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code HSN·March 29, 2021
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·May 28, 2025
DIMENSION® CLINICAL CHEMISTRY SYSTEM
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS INC - GLASGOW·Product code DIP·October 1, 2014
HUDSON SILENT HUMIDIFIER ADAPTOR
FDA Adverse Event
Malfunction
·TELEFELX MEDICAL·Product code BTT·May 23, 2013
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER INC.·Product code JJE·June 16, 2011
AMS URIC ACID For the In vitro quantitative determination of Uric Acid in serum Quantitative determination of Uric Acid in serum.
FDA Enforcement
Class II
·Terminated·AMS Diagnostics, LLC·April 2, 2014
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 8, 2024
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 19, 2023
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·May 28, 2024
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·July 15, 2025
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·December 2, 2022
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Malfunction
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 22, 2024
PROPHECY INFINITY EU PATIENT SPECIFIC GUIDES
FDA Adverse Event
Injury
·WRIGHT MEDICAL TECHNOLOGY INC·Product code HSN·October 11, 2024