23 results
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34ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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primeMidline Catheters
FDA 510(k)
FDA Class 2
·General Hospital
Ophthalmic Ring
FDA UDI
KATENA PRODUCTS, INC.·00841668100844·MCNEILL GLOBAL FIXATION RING SMALL
OSSPRAY SYLC CR
FDA 510(k)
FDA Class 1
·Dental
IMIX INSIGHT X-RAY SYSTEMS
FDA 510(k)
FDA Class 2
·Radiology
PRECISION SPECTRA ?
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·October 24, 2025
TRILOGY 100
FDA Adverse Event
Malfunction
·RESPIRONICS INC.·Product code CBK·October 10, 2014
CURLIN IV PUMP
FDA Adverse Event
Malfunction
·MOOG MEDICAL DEVICES GROUP·Product code FRN·May 30, 2013
ESPRIT VENTILATOR
FDA Adverse Event
Malfunction
·RESPIRONICS CALIFORNIA, INC.·Product code CBK·July 23, 2011
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·April 4, 2018
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 15, 2017
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·November 7, 2017
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·May 15, 2019
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·August 18, 2017
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·April 4, 2018
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Malfunction
·COOK INC·Product code DYB·April 5, 2018
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·April 11, 2018
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·April 2, 2018
MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET
FDA Adverse Event
Injury
·COOK INC·Product code DYB·March 30, 2018
Allura Xper FD20 OR Table Product Codes: (1)722023, (2) 722035, (3) 722015; Associated 510(k) numbers: K102005, K130842, K130638, K133292, K141979, K161563, K162859, K033737, K041949;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·October 1, 2025
ALLURA Xper FD20 OR Table; System Code: (1) 722015, (2)722023, (3)722035;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026