72 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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MIM - Centiloid Scaling
FDA 510(k)
FDA Class 2
·Radiology
Aneroid Sphygmomanometer
FDA 510(k)
FDA Class 2
·Cardiovascular
CONE BEAM 3D AND 2D PANORAMIC DENTAL IMAGING SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
U-BLADE SET, TI GAMMA3 10.5X100MM
FDA Adverse Event
Injury
·STRYKER OSETOSYNTHESIS KIEL·Product code HSB·December 18, 2012
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·July 29, 2025
COOK CELECT® PLATINUM NAVALIGN JUGULAR VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·November 12, 2024
IMPLANT INSERTER
FDA Adverse Event
Malfunction
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code LXH·November 6, 2014
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 18, 2013
UNKNOWN TRIDENT PSL CUP
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JDG·November 18, 2015
VITEK¿ 2 Gram Positive Susceptibility card (AST-P608), REF 22336, 20 cards per carton.
FDA Enforcement
Class II
·Terminated·Biomerieux Inc·June 21, 2017
VITEK 2 Gram Positive Susceptibility card (AST-P608), REF 22336, 20 cards per carton.
FDA Recall
Terminated
·Biomerieux Inc·Product code N/A·April 20, 2017
COOK CELECT® PLATINUM NAVALIGN FEMORAL VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·May 20, 2026
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·April 20, 2026
COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·March 20, 2026
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·April 22, 2026
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·January 9, 2025
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·March 20, 2026
COOK CELECT® PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Malfunction
·WILLIAM COOK EUROPE·Product code DTK·May 12, 2026
UNKNOWN
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·September 12, 2024
COOK CELECT PLATINUM NAVALIGN UNISET VENA CAVA FILTER SET
FDA Adverse Event
Injury
·WILLIAM COOK EUROPE·Product code DTK·December 8, 2025